FDA Sent These 7 Warning Letters for Food Companies | December 2017

We took a snapshot of the 7 warning letters the FDA sent to food companies last month. Food violations ranged from failing to remove the presence of Listeria to failing to provide screening against pests.

From companies in Brooklyn, Georgia, and more, here they are (starting with the most recent):

• Maine Natural Health, Inc., Warren, ME – 4 violations:
  • Failed to establish specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a).
  • Failed to collect representative samples of a subset of finished batches of each dietary supplement that the company manufactures, which it identifies through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution to verify that the finished batch of dietary supplement meets product specifications, as required by 21 CFR 111.80(c).
  • Failed to meet an established specification, the company’s quality control personnel did not reject the component or dietary supplement, nor did the personnel approve a treatment, an in-process adjustment, or reprocessing that would ensure the quality of the finished dietary supplement and that the dietary supplement was packaged and labeled as specified in the company’s master manufacturing record (MMR), as required by 21 CFR 111.77(a) and 111.113(b)(2).
  • Failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that the company manufactures, and for each batch size, to ensure uniformity in the finished batch, from batch to batch, as required by 21 CFR 111.205(a).
• Gold Star Smoked Fish Corp., Brooklyn, NY – 2 violations:
  • The FDA laboratory analyses of the environmental samples (i.e., swabs) identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in facility.
  • Processing RTE cold and hot smoked seafood products under conditions that cause RTE cold and hot smoked seafood products to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4).
• BrainAlert, LLC, Lynnwood, WA – 3 violations:
  • Failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55.
  • Failed to make and keep written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)
  • Failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553
• Dynamic Technical Formulations, Roswell, GA – 7 violations:
  • Failed to ensure that the company’s manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105
  • Failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that the company manufactures, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205
  • Failed to prepare a batch production record every time the company manufactured a batch of a dietary supplement, as required by 21 CFR 111.255(a)
  • Failed to establish a specification for every point, step, or stage in the manufacturing process where control is necessary to the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a)
  • Failed to identify each unique lot within each unique shipment of components that the company receives and any lot of components that they produce in a manner that allows them to trace the lot to the supplier, the date received, the name of the component, the status of the component; and to the dietary supplement they manufactured and distributed, as required by 21 CFR 111.155(d)(1)
  • Failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that the company distributes, as required by 21 CFR 111.83(a)
  • Failed to make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained, as required by 21 CFR 111.14(b)(2)

• GnuPharma Corporation, Owasso, OK – 5 violations:
  • Failed to establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a).
  • Failed to establish and follow written procedures for quality control operations, as required by 21 CFR 111.103
  • Failed to prepare and follow a written master manufacturing record for each unique formulation of the company’s dietary supplement products that they manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a).
  • Failed to prepare a batch production record every time the company manufactures a batch of their dietary supplement products, as required by 21 CFR 111.255(a).
  • Failed to establish and follow written procedures for fulfilling the requirement for equipment and utensils under 21 CFR 111.25, including written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment, as required by 21 CFR 111.25(b)
• K & S Food Center, LLC, Hartford, CT – 2 violations:
  • Firm did not follow the monitoring, record keeping and verification procedures included in HACCP plan.
  • Firm does have an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing, but that individual is not performing the record review involving critical control point monitoring, the taking of corrective actions and the calibration of process control instruments used in critical control point monitoring.
• Bedessee Imports, Inc., Brooklyn, NY – 3 violations:
  • Failed to provide, where necessary, adequate screening or other appropriate protection against pests as required by 21 CFR 110.20(b)(7)
  • Failed to provide sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1)
  • Failed to store and dispose of rubbish to minimize the potential for waste becoming an attractant and harborage or breeding place for pests, as required by 21 CFR 110.37(f)