The U.S. Food and Drug Administration’s Los Angeles District Director, Alonza E. Cruse, has issued a warning letter to LA-based P & D Seafood Company Inc. regarding comments the company offered after an inspection last September.
FDA’s district office used the warning letter to express its concerns about shortcomings the agency found in the company’s response to its earlier concerns.
For example, FDA’s warning letter states: “Your corrective action plan for ‘Scombroid Fish’ at the (b)(4) critical control point to control the hazard of ‘Chemical Scombrotoxin formation’ lists a corrective action of (b)(4). However, you should evaluate the pertinent hazard (histamine formation).”
The letter goes on to state, “Your ‘Canned Raw Scallops’ and ‘Canned Pasteurized Crabmeat’ plans list the hazard of ‘Chemical,’ which is referred to in your hazard analysis as ‘Toxin formed when temperature abused.’ However, your plan should specify the hazard of Clostridium botulinum growth and toxin formation.”
The agency offered this comment about imported products: “Product specifications should ensure that the product is not adulterated under section 402 of the Act. However, the specifications you provided with your response do not include any potential safety hazards (i.e., water activity, pH, histamine formation, pathogen limits, aquaculture drugs, parasites etc.). Please refer to Chapter 2 and 3 of the Fish and Fishery Products hazards and Controls Guidance, 4th Edition.”
Although dated March 26, the warning letter was only recently posted on FDA’s website.
Separately, a June 9 warning letter was sent to Kenneth E. Newell, owner of Newell Farms in Trufant, MI, from the agency’s Detroit District Office. In that letter, Newell was warned about selling an animal for slaughter that later tests found to contain illegal drug residues. Here are some of the specifics:
On or about Oct. 22, 2013, FDA states that Newell sold an animal for slaughter and that a “United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 6.28 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney and 0.879 ppm of flunixin in the liver.”
As explained in the letter, FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i) (21C.F.R. 556.113(b)(3)(i)). FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver tissue of cattle as codified in 21, C.F.R. 556.286(b)(1)(i).
“The presence of these drugs in edible tissue from this animal in these amounts causes the food to be adulterated,” the warning letter stated.
Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.
