The U.S. Food and Drug Administration has published nine warning letters it issued to food manufacturers and processors at the end of January and the start of February.
Orth Farms of Eaton, NY, B & E Dairy of Barstow, CA, and Hillegass Dairy of Berlin, PA, received warning letters after selling cows and calves for slaughter that were considered adulterated because of unacceptable levels of drug residues in their tissues.
A fourth dairy – Campbell Dairy Farm of Limestone, TN – received a letter about the extra-label use of an animal drug without the supervision of a veterinarian.
FDA inspected Mongiello Italian Cheese Specialties of Hurleyville, NY, in response to finished product and environmental samples from the facility that were positive for Listeria. The inspectors found several violation of FDA’s Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulations, including the failure to address potential contamination of food and food-contact surfaces by drips, condensation and employee’s arms, failure by employees to sanitize hands thoroughly, and failure to adequately screen for or protect against pests.
Two shell egg production facilities received warning letters about violations of Salmonella Enteritidis (SE) regulation. Swiss Mountain View Egg Farm of Ramona, CA, failed to have a written SE prevention plan, perform environmental testing for SE, prevent wild birds and cats from entering poultry houses, and remove vegetation and debris outside poultry houses that may harbor pests.
Stanton Brothers of Centralia, MO, did not conduct environmental testing, ensure that SE would not be introduced or transferred into or among poultry houses, remove debris within a poultry house and vegetation and debris from outside, monitor for flies or rodents, limit visitors, or maintain records documenting compliance with biosecurity measures.
A seafood company in Nicaragua also received a warning letter about inadequate responses to an August inspection. Huwen Huang Import and Export was found in violation of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation for not conducting hazard analysis for each kind of fish and not listing critical control points.
Finally, NatureAll-STF Holding of Salt Lake City, UT, violated CGMP regulations for dietary supplements. Of the numbers violations listed, FDA’s letter stated that the company does not conduct any tests or examinations to verify the identity of incoming dietary ingredients; does not conduct any type of finished product testing for identity, purity, strength, composition or certain types of contamination; does not have written procedures for the responsibilities of quality control operations; has not prepared or followed a written master manufacturing record for each unique formulation of dietary supplement it manufactures, and does not calibrate instruments used in manufacturing.
Within the letter, FDA noted the company had responded to each CGMP violation in a letter dated June 17, 2013, but despite stating the company would establish and implement plans to address each issue, the agency countered that NatureAll did not include any documentation of these plans or commit to any timelines.
NatureAll was also warned about misbranding violations, including failing to identify the products by using the term “dietary supplement,” failing to identify parts of plants from which some of the botanical dietary ingredients are derived, and not including contact information for reporting a serious adverse event.
Furthermore, the company has not verified information from suppliers’ certificates of analyses and may have discarded records within the retention period for inspection.
In each letter, FDA requested that the farms and companies provide written responses detailing steps taken to bring the firms into compliance with food safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence.
