The FDA sent warning letters to each of the companies in September and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.
Douglas Chambers Dairies Inc.
In a Sept. 26 warning letter to dairy owner Mary Watts, the FDA described violations observed during a inspection visits on April 24, 26, and 28 at the firm’s dairy operation in Macon, GA. According to the warning letter, investigators found that the firm holds animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the human food supply.
“You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues,” according to the warning letter.
Specifically, the firm failed to maintain adequate treatment records, and the firm’s records did not include the drug administered, dosage given, route of administration, and documentation of required withdrawal time for meat and milk.
“Further, you did not have a system in place to review treatment records prior to offering an animal for slaughter for human food, to assure that drugs have been used only as directed and that appropriate withdrawal times have been observed.”
The inspector also noted that the firm failed to maintain an adequate inventory system for determining the quantities of drugs used to medicate their animals. This include the list of drugs, quantities, lot numbers, date used or expiration dates.
“You also fail to segregate treated animals. Both hospital pens at your farm are used to store both medicated and non-medicated cows in an intermingled manner. Treated cows are not quarantined, segregated or identified as medicated at any time, including storage in hospital pens.”
As a producer of animals offered for use as food, firms are responsible for ensuring that their overall operation and the food they distribute is in compliance with the law.
Nashoba Brook Bakery LLC
In a Sept. 22 warning letter to company owner, president and CEO John D. Gates and Stuart J. Witt, head baker and co-owner, the FDA described violations observed during an inspection from May 25 through June 8 at the firm’s ready-to-eat manufacturing facility in Concord, MA. According to the warning letter, the investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods.
“At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection,” which renders the firm’s products adulterated “…in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.”
Additionally, the firm’s Nashoba Granola product was inspected for labeling regulations, which resulted in the discovery of violations, and misbranding.
The following significant violations are noted regarding the adulterated foods:
The firm failed to conduct all food manufacturing, including packaging and storage, under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food;
The firm failed to maintain equipment and utensils and finished product containers in an acceptable condition through appropriate cleaning and sanitizing;
The firm failed to maintain buildings, fixtures, and other physical facilities in a sanitary condition and keep in sufficient repair to prevent food from becoming adulterated;
The firm failed to ensure equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination;
The firm failed to provide, where necessary, adequate screening or other protection against pests;
The firm failed to have employees remove unsecured jewelry or other objects which might fall into food, equipment, or containers; and
The firm failed to properly store equipment that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.
The following observations are noted regarding the misbranding:
The firm’s Nashoba Granola and Whole Wheat Bread products are fabricated from two or more ingredients, but the labels fail to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients;
The firm’s Nashoba Granola fails to bear an acceptable nutrition facts label; and The firm’s Nashoba Granola and Whole Wheat Bread product labels fail to include a net quantity of contents statement.
Texas Plum Line
In a Sept. 22 warning letter to company owner Connie J. Bingham, the FDA described violations observed during an inspection from June 19 to 22 at the firm’s low-acid food facility in Amarillo, TX. According to the warning letter, the firm manufactures low-acid food products and low water activity controlled products. Serious violations of regulations for Emergency Permit Control, under the Current Good Manufacturing Practice (CGMP) regulation for foods, were observed.
“Accordingly, we have determined that your LACF products and low water activity products are adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”
All manufacturers of low-acid canned foods are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations related to the processing of LACF and current good manufacturing practices.
Significant violations of Emergency Permit Control & LACF and CGMP observations are as follows:
The firm failed to register with the FDA as a commercial processor of low-acid foods. A commercial processor of low-acid foods is required, no later than 10 days after first engaging in the manufacture, processing, and packaging of thermally processed low-acid foods in hermetically sealed containers in any state;
“…our inspection indicated that your firm processes the low-acid food, Special Dark Chocolate Cake with Maraschino Cherries, without registering with the FDA.”
The firm failed to have a scheduled process established by a qualified person who has expert knowledge through appropriate training and experience of thermal processing requirements for low-acid foods in hermetically sealed containers and have adequate facilities for making such determinations;
firm failed to mark each hermetically sealed container of low-acid processed food with an identifying code that identifies in code the establishment where packed, the product contained therein, the year packed and the day packed; and The firm failed to monitor the water activity to prevent the growth of undesirable microorganisms, particularly those of public health significance.
J & B Seafood, Inc.
In a Sept. 19 warning letter to company owner and president Raymond T. Barbour, the FDA described violations observed during an inspection from June 19-23 at the firm’s seafood processing facility in Coden, AL. According to the warning letter, investigators found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, and the Current Good Manufacturing Practice regulation for foods.
The FDA declared the firm’s fresh picked crabmeat adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
Seafood handlers, packers and manufacturers are required by federal law to comply with seafood Hazard Analysis and Critical Control Point (HACCP) regulations, which include maintaining temperature control, training employees and documenting cleaning and sanitization of facilities and equipment.
“…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, renders the fish or fishery products adulterated.”
Regarding HACCP regulations, “the firm did not take a corrective action to control pathogen survival when your process for cooked crabmeat deviated from [their] critical limit at the cooking critical control point.“
Specifically, “a review of [their] Daily Cooking Log demonstrates [they] did not take corrective action that ensured the affected product was segregated, held for evaluation to determine acceptability, re-cooked and the cause of the deviation was corrected.”
In addition, live flies were observed repeatedly landing on cooked crabs, cooked crab parts and cooked crab food contact surfaces. Investigators observed a foreign black material encrusted in the etching of an etched handled knife after it was washed and sanitized. Investigators observed three employees cooking and preparing crab with unrestrained hair, and an employee was repeatedly observed wiping her nose while touching cooked crabs without washing her hands.