Wednesday, 19 April 2017

FDA warning letter to Safe Harbour Seafood, Inc

  

Black HHS-Blue FDA Logo

 


 
New Orleans District
404 BNA Drive
Building 200- Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802 

April 10, 2017
 
WARNING LETTER NO. 2017-NOL-07
 
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
James R. Shutt, President
Safe Harbour Seafood, Inc.
5822 Heritage Circle
Bon Secour, Alabama 36511-3401
 
Dear Mr. Shutt:
 
We inspected your seafood processing facility, located at 5822 Heritage Circle, Bon Secour, Alabama on February 13-16, 2017. We found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 342(a)(4)]. Accordingly, your fishery products are adulterated, because they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's Internet home page at www.fda.gov.
 
We acknowledge receipt of your letter, dated February 24, 2017, responding to the FDA 483, Inspectional Observations (FDA 483), issued to you on February 16, 2017. This letter will become part of our official files. Our evaluation of your response is discussed below. Violations revealed during the inspection include, but are not limited to:
 
1.    You must implement the monitoring procedures and frequency which you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedures included in your HACCP plans as follows:
 
A.  The monitoring procedures, for each lot of scombrotoxin species fish received, of obtaining harvest vessel records and monitoring the conditions of the fish at the “receiving from harvest vessels” critical control point to control the hazard of “Scombrotoxin formation” listed in your HACCP plan for “Scombrotoxin Species Fish” were not followed.
 
Specifically, this monitoring procedure was not being followed in that (b)(4) were not being obtained or maintained to show the conditions included in this HACCP plan were being met (such as the time of death for the fish, when/if ice was used to keep the fish at the acceptable temperature, the date and time of off-loading, whether ice was still present on the fish at off-loading, and the internal temperature of the fish at the time of off-loading). In addition, this HACCP plan calls for the (b)(4) and, there were no records available indicating such (b)(4)
 
Your response provides your planned corrective action to this item and includes a (b)(4) however you have not provided evidence to demonstrate the implementation of this correction (which should include completed forms when this process is implemented). Your response also notes that you have purchased new (b)(4) of the (b)(4) and indicates these (b)(4) will be calibrated on (b)(4).  Since your current HACCP plan for scombrotoxin producing fish calls for (b)(4) you should provide clarification and update your HACCP plan to reflect what your (b)(4) schedule will be for your (b)(4) and provide your basis for the (b)(4) schedule. 
 
B.  The monitoring procedure, for every lot of shrimp received, of obtaining the (b)(4) that sulfites were not used on the lot at the “receiving” critical control point  to control the hazard of “sulfites” listed in your HACCP plan for “Fresh Shrimp” was not followed.
 
Specifically, this monitoring procedure was not followed in that your firm was not obtaining or maintaining (b)(4) documenting sulfites were not used on the lots of shrimp by the suppliers for lots of shrimp received from (b)(4) through (b)(4) 
 
Your response provided the corrective action of including the statement (b)(4) on future fresh shrimp invoices and to obtain a completed (b)(4) from each supplier of fresh shrimp. You should provide evidence showing the full implementation of this corrective action when fresh shrimp are received.
 
C.  The monitoring procedure, for every lot of fresh whole fish (parasite carriers) sold to secondary processors, of obtaining (b)(4) from the processors at the “Purchasing” critical control point to control the hazard of “Parasites” listed in your HACCP plan for “Fresh Whole Fish (parasite carriers)” was not followed.
 
Specifically, this monitoring procedure was not followed in that your firm was not obtaining or maintaining (b)(4) for the secondary processors of these fish. As per this HACCP plan, such forms (b)(4)
 
Your response indicates that you have supplied the (b)(4) to your secondary processers of your fresh whole fish (parasite carriers) and that you have (b)(4).  In order to verify this correction we would need to see evidence that your secondary processers have (b)(4)
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product and/or enjoin your firm from operating.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as harvest vessel records, receiving records, supplier guarantees, parasite fish release forms, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123), and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Section 743 of the Act, [21 USC 379j-31], authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs.  A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 USC 379j-31(a)(2)(B)].  For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: David Van Houten, Compliance Officer, 404 BNA DriveBuilding 200 – Suite 500Nashville, TN 37217. If you have questions, concerning the contents of this letter, you may contact Mr. Van Houten at (615) 366-7813.
 
Sincerely,
/S/                                                           
Ruth P. Dixon
District Director
New Orleans District

Thursday, 28 April 2016

Fake university in India 2016


    Bihar

  1. Maithili University/Vishwavidyalaya, Darbhanga, Bihar. 

    Delhi
  2. Commercial University Ltd., Daryaganj, Delhi.
  3. United Nations University, Delhi.
  4. Vocational University, Delhi.
  5. ADR-Centric Juridical University, ADR House, 8J, Gopala Tower, 25 Rajendra Place, New Delhi - 110 008.
  6. Indian Institute of Science and Engineering, New Delhi. 

    Karnataka
  7. Badaganvi Sarkar World Open University Education Society, Gokak, Belgaum, Karnataka. 

    Kerala
  8. St. John’s University, Kishanattam, Kerala. 

    Maharashtra
  9. Raja Arabic University, Nagpur, Maharashtra. 

    Tamil Nadu
  10. D.D.B. Sanskrit University, Putur, Trichi, Tamil Nadu. 

    West Bengal
  11. Indian Institute of Alternative Medicine, Kolkatta.
  12. Institute of Alternative Medicine and Research,8-A, Diamond Harbour Road, Builtech inn, 2nd Floor, Thakurpurkur, Kolkatta - 700063 

    Uttar Pradesh

  13. Varanaseya Sanskrit Vishwavidyalaya, Varanasi (UP) Jagatpuri, Delhi.
  14. Mahila Gram Vidyapith/Vishwavidyalaya, (Women’s University) Prayag, Allahabad, Uttar Pradesh.
  15. Gandhi Hindi Vidyapith, Prayag, Allahabad, Uttar Pradesh.
  16. National University of Electro Complex Homeopathy, Kanpur, Uttar Pradesh.
  17. Netaji Subhash Chandra Bose University (Open University), Achaltal, Aligarh, Uttar Pradesh.
  18. Uttar Pradesh Vishwavidyalaya, Kosi Kalan, Mathura, Uttar Pradesh.
  19. Maharana Pratap Shiksha Niketan Vishwavidyalaya, Pratapgarh, Uttar Pradesh.
  20. Indraprastha Shiksha Parishad, Institutional Area,Khoda,Makanpur,Noida Phase-II, Uttar Pradesh.
  21. Gurukul Vishwavidyala, Vridanvan, Uttar Pradesh. 

    Odisha

  22. Nababharat Shiksha Parishad, Anupoorna Bhawan, Plot No. 242, Pani Tanki Road,Shaktinagar, Rourkela-769014.

    Published by UGC website
    and * Bhartiya Shiksha Parishad, Lucknow, UP - the matter is subjudice before the District Judge - Lucknow

Saturday, 11 July 2015

‘Jumping genes’ may drive oesophageal cancer

Cancer Research UK scientists have found that ‘jumping genes’ may add to the genetic chaos behind more than three-quarters of oesophageal cancer cases, according to research published in BMC Genomics(link is external) today.
The scientists, from the University of Cambridge(link is external), used cutting-edge technology that can read DNA to study the genes of 43 oesophageal tumour and blood samples to discover how much these mobile genetic sequences travel.
“These jumping genes play hopscotch across our genetic code in cancer cells more than in normal cells." - Dr Paul Edwards
‘Jumping genes’, called L1 elements, can uproot themselves and move to new areas in the DNA, sometimes accidentally moving into genes that control the cell’s growth.
They found evidence that this happened around 100 times in each tumour sample, and in some tumours it happened 700 times.
If a jumping gene lands in or near an important gene that controls cell growth, it can wreak havoc, changing how the gene works so that it inadvertently tells the cell to grow and divide out of control – which could lead to cancer.
Study author Dr Paul Edwards, at the Cancer Research UK Cambridge Institute(link is external), said: “These jumping genes play hopscotch across our genetic code in cancer cells more than in normal cells. When one of these mobile genetic sequences plants itself in the middle of a gene that controls the cell’s growth it radically alters how the cell behaves, which can sometimes cause cancer.
“Research has shown that this might also happen in lung and bowel cancers. So it’s vital we find out more about how the cells do this in a bid to find ways to treat these cancers.”
The research is part of the International Cancer Genome Consortium (ICGC)(link is external) – a global project using the latest gene sequencing technology to reveal the genetic changes behind cancer. The oesophageal cancer project is funded by Cancer Research UK’s Catalyst Club*.
Dr Kat Arney, Cancer Research UK’s science information manager, said: “Oesophageal cancer is one of the hardest cancers to treat, and we are committed to funding more research to find out its underlying causes. These new findings reveal more about the genetic chaos that underpins oesophageal tumours, and could one day help us develop better ways to diagnose, treat and monitor the disease.”
Reference
Paterson et al. Mobile element insertions are frequent in oesophageal adenocarcinomas and can mislead paired end sequencing analysis. BMC Genomics. DOI: 10.1186/s12864-015-1685-z.

Wednesday, 20 May 2015

Data Disclosure Leads Researchers to End Study of Obesity Drug

A study of an obesity drug has ended after the manufacturer released early and ultimately misleading data, researchers said on Tuesday.
The company, Orexigen Therapeutics, disclosed in March that early results from a clinical trial of its drug Contrave had shown a 41 percent reduction in the risk of heart attacks, strokes and death from cardiovascular causes. Orexigen’s stock shot up, and the information no doubt helped lift sales of Contrave.
But the academic researchers who oversaw the study said on Tuesday that Orexigen had violated an agreement that the early results were not going to be shared widely, even within the company.
Moreover, as participants in the trial were followed for a longer period of time, the benefit of the drug in reducing cardiovascular risks vanished.
The researchers, in a news release issued by the Cleveland Clinic, said they took the unusual step of terminating the study and releasing the more updated results.
“We felt it was unacceptable to allow misleading interim data to be in the public domain and be acted upon by patients and providers,” Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and head of the trial’s steering committee, said in an interview.
He said Orexigen had “acted improperly and unethically in violating the data access agreement” and the premature release of data had made it difficult to continue the study.
It’s unlikley that patients would want to stay in the trial and risk getting a placebo if they thought the drug, which is already available on the market, could reduce their risk of heart attacks.
The Food and Drug Administration, citing similar reasons, has already ordered Orexigen to conduct another large study of the drug to rule out an increase in cardiovascular risk.
Orexigen said in a statement on Tuesday that it had wanted to shut down the older study in December. It also denied misleading anyone, saying that it had stated “plainly and clearly” that the data it released was preliminary and that the cardiovascular benefits of Contrave had not been established.
Contrave, which was approved in September, is one of four new prescription weight-loss drugs that have come to market since 2012, following more than a decade in which there were no new medicines.
Despite the fact that one-third of American adults are obese, the drugs have not sold well for a variety of reasons, including lack of coverage byMedicare and some insurers, modest weight loss, a history of safety problems with diet drugs, and a feeling among doctors and patients that obesity is not a disease.
Still, Contrave is off to a stronger start than the others, with United States sales of $11.5 million in the first quarter. The drug is closing in on Belviq, which has been on the market longer, for the lead in prescriptions, according to Simos Simeonidis, an analyst at RBC Capital Markets. Belviq was developed by Arena Pharmaceuticals and Eisai.
The F.D.A. declined to approve Contrave in 2011 because the drug slightly raised blood pressure and pulse rates, a sign that it might increase the risk of heart attacks and strokes. The agency told Orexigen to conduct a large study to rule out that risk.
Under agreement with the F.D.A., Orexigen looked at the data after 94 cases of heart attack, stroke or death from cardiovascular causes had occurred — about 25 percent of the expected total in the trial. Those early results effectively ruled out that Contrave doubled the risk of cardiovascular problems, clearing the way for the drug to be approved.
But in an agreement with the academic steering committee, the data was supposed to be known only by a small group within Orexigen charged with filing the application for F.D.A. approval.
Dr. Nissen said many more people were told. And when the company found out that those getting Contrave actually had a 41 percent lower risk of a heart attack, stroke or death from cardiovascular death, the company filed a patent application covering use of the drug to prevent cardiovascular problems.
When the patent was granted in early March, Orexigen disclosed this in a filing to the Securities and Exchange Commission, apparently viewing it as material to the company. The filing contained the preliminary trial results.
The company’s action drew an unusual rebuke from a senior F.D.A. official, who said in interviews that data from so early in a trial was very unreliable.
The steering committee said on Tuesday that as the trial continued, more patients getting the drug began having heart attacks and strokes, or died. After 192 adverse cardiovascular events the trail was halfway completed, and the earlier reported benefit was no longer statistically significant. There were 102 events in the placebo group compared with 90 among those who received Contrave.
Orexigen also said it was fighting with its marketing partner, Takeda Pharmaceutical in part over which company will have to pay for the new cardiovascular trial. Orexigen said Takeda had initiated a formal dispute process claiming a material breach of the agreement between the companies.