Showing posts with label drug. Show all posts
Showing posts with label drug. Show all posts

Monday, May 20, 2019

EU - Report on Chemical Residues in Animals and Animal Products

The EFSA (European Food Safety Authority) released their 2017 report on the presence of residues of  veterinary medicinal products and certain substances in live animals and animal products in the 
European Union (EU).  The study look at pharmaceutical compounds, antimicrobials, and environmental contaminants such as mycotoxins.   The results showed good compliance with regulations.  Overall in 2017, the percentage of non-compliant targeted samples (0.35%) was comparable to the previous 10 years (0.25%–0.37%).

This may serve as a good reference if importing animal products from the EU.

EFSA Technical Report
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2019.EN-1578
Report for 2017 on the results from the monitoring of veterinary medicinal product residues and other substances in live animals and animal products
APPROVED: 8 February 2019

Monday, September 24, 2018

$18 Million in Smuggled Drugs Found in Shipment of Bananas

In Texas, a shipment of bananas was found to be carrying a hidden load of cocaine..540 packages.....18 million dollars worth.

The Produce News
http://theproducenews.com/the-produce-news-today-s-headlines/25022-this-18-million-drug-bust-is-bananas
This $18 million drug bust is bananas
September 24, 2018

Thursday, June 9, 2016

Adult Multivitamin Gummies Recalled After Company Fails to Complete Testing for Salmonella and Staph

Nature Made is recalling their Gummies Adult Multivitamins after they found that Salmonella and Staphylococcus testing was not properly completed on the batches those batches recalled.

It is hard to know the risk of these products without knowing the test results the company had found on a historical basis.  One would guess minimal.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm505706.htm
FDA Recall Notice
Nature Made® Recalls Various Products Because of Possible Health Risk
For Immediate Release
June 8, 2016

Wednesday, November 12, 2014

Applying the Drug Guidance "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection" to Food Operations

FDA recently issued a guidance for drug related companies titled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing to Permit Drug Inspection". Some have suggested that this type of guidance may be extended to food processing facilities that fall under FDA jurisdiction.

It is stated in this guidance:
It is a prohibited act under sections 301(e) and 301(f) of the FD&C Act to refuse to permit entry or inspection or refuse to permit access to or copying of certain specified records.10 New section 501(j) of the FD&C Act, as added by FDASIA section 707, now deems a drug to be adulterated if "…it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection."
 Basically, if they can't see what they want, when they want, that product is adulterated.

The categories defined in the guidance include 1) Delay of inspection (pushing back an inspection, holding up during an inspection, delaying of getting records), 2) Denial of inspection, 3) Limiting an inspection (limiting access, limiting photography, limiting access to records or the copying of those records, and limiting or preventing the collection of samples, and 4) Refusal to permit entry.

It may be worth the time to gain an understanding of this guidance and what constitutes the definitions in preventing access.  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf