FDA warns companies over import, adulteration by new animal drugs and hazard analysis violations

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.


A.N.N. Imports LLC
North Hollywood, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products

In a May 2 warning letter, the FDA described a Dec. 7-22, 2021, Foreign Supplier Verification Program (FSVP) inspection of A.N.N. Imports LLC in North Hollywood, CA.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP  for the food products that they import:

  • Marinated Chervil imported from (redacted)
  • Solomon’s Seal imported from (redacted)
  • Peach Compote imported from (redacted)
  • Peach Nectar imported from (redacted)

The full warning letter can be viewed here.

Yippee Farms LLC
Mount Joy, PA

A food firm in Pennsylvania is on notice from the FDA for violations of the Federal Food, Drug, and Cosmetic Act.

In a May 5, warning letter, the FDA described a Dec. 8 and 10, 2021, inspection of Yippee Farms LLC’s dairy operation in Mount Joy, PA.

The FDA’s inspection revealed that the firm was responsible for causing drug residues of meloxicam and sulfadimethoxine in the kidney tissue of bob veal calf (redacted) and resulted in the issuance of an FDA Form 483.

Adulteration of animals offered for human consumption
The FDA investigation found that they hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, they failed to maintain complete treatment records for a bob veal calf with farm tag (redacted) when their employee did not record the administration of meloxicam and sulfadimethoxine on the pen treatment record for this animal.

Due to the incomplete treatment records, the calf with farm tag (redacted) was sold for slaughter before the proper meat withdrawal time indicated on the prescription label for the human drug meloxicam. Additionally, the firm’s treatment records, in general, do not identify the condition being treated for their medicated heifer calves. Food from animals held under such conditions is adulterated.

Adulteration of new animal drugs
FDA inspection also revealed that the firm adulterated the human drug meloxicam (NDC (redacted)) and the drug (redacted) (sulfadimethoxine, NADA (redacted)) because they failed to use the drugs in conformance with their approved labeling (“extra label use”). 

FDA investigation found that their extra label use of meloxicam and (redacted), however, failed to comply with these requirements.

Specifically:

  • Around March 3, 2021, their employee treated a bob veal calf identified with farm tag (redacted) with meloxicam and (redacted) (sulfadimethoxine) for scours. Additionally, they stated that they routinely administer meloxicam for scours. However, the veterinary prescription label stated that meloxicam was prescribed to only treat pain in calves due to dehorning. Their use of the drug for scours was therefore an extra label use.
  • The firm administered meloxicam to bob veal calf identified with farm tag (redacted) in an extra label manner by not following the withdrawal period set forth in the veterinary prescription label, which is (redacted). They stated that an employee medicated this animal with meloxicam at an unknown date prior to the calf being sold. This calf was only (redacted) old when slaughtered for food; therefore, the calf could not have been held for the required withdrawal time of (redacted).
  • They administered (redacted) (sulfadimethoxine) in an extra label manner by treating a preruminant bob veal calf identified with farm tag (redacted) for scours. The approved labeling of (redacted) (sulfadimethoxine) (redacted) states in part, “(redacted)”.

Their extra label use of meloxicam and (redacted) (sulfadimethoxine) were not under the supervision of a licensed veterinarian.

The full warning letter can be viewed here.

Russ Davis Wholesale Inc.
Wadena, MN

A food firm in Minnesota is on notice from the FDA for serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation.

In an April 28 warning letter, the FDA described a Dec. 14-16, 20 and 22, 2021, and Jan. 14 and 19, 2022, inspection of Russ Davis Wholesale Inc.’s ready-to-eat (RTE) food and beverage facility in Minnesota.

The FDA’s inspection revealed that the firm was not in compliance with HACCP regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

Juice HACCP

  1. The firm failed to take corrective actions when a deviation from a critical limit occurred during the manufacture of cold pressed citrus juice. Review of their (redacted) recording charts that monitor the (redacted) critical limit of their citrus fruit (redacted) treatment that uses (redacted) to achieve a minimum 5-log reduction in the pertinent microorganism, revealed deviations from the critical limits identified in their Juice HACCP plan for cold pressed citrus juice with no corrective actions on Nov. 11, 12, 15 and 16, 2021. On these dates their (redacted) charts recorded (redacted) their critical limit of (redacted), but they did not take corrective action. Also, in one instance the (redacted) was not working and they did not take corrective action. Additionally, the corrective action listed at CCP (radacted) ((redacted) treatment) is “If critical limit for (redacted) is not met, (redacted) must be reprocessed or disposed of.” This corrective action does not ensure that the cause of the deviation is corrected.
  2. The firm did not validate that their HACCP plan is adequate to control food hazards when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way. Specifically, they had an outside laboratory perform a process validation study, dated March 21, 2021, to determine whether the (redacted) is an effective (redacted) treatment critical control point (CCP) to achieve a minimum 5-log reduction for the control of (redacted). The validation concluded that (redacted) provides a minimum 5-log reduction in lemons, mandarins, limes, and oranges; a (redacted) is required for grapefruit. The validation further stated that verification of the (redacted) is an important part of this CCP. The firm started producing (redacted) treated citrus juice in April 2021 without adequate verification of the (redacted) treatment as performed at their facility.

The validation study they relied on was done in a laboratory setting with (redacted) using a device to monitor the (redacted) that been been verified by a (redacted). (Redacted) pieces of each fruit were used in the study; they were (redacted).

  • They did not validate that the (redacted) treatment process using their (redacted) can mimic the laboratory study conditions completed with dissimilar equipment.
  • The (redacted) in their (redacted) is not (redacted) to ensure (redacted) within the (redacted) during processing.
  • A (redacted) study was not conducted to identify any (redacted) in their (redacted), so the (redacted) can be monitored accurately and effectively under typical and worst-case operating conditions.
  • The firm packs the fruit in (redacted) such that fruit is pressed against each other and against the (redacted) walls. They did not determine if this orientation provides complete (redacted) in order to meet the critical limits identified in the study.
  • The (redacted) monitoring probe that reads to the (redacted) display panel is located near the (redacted) within (redacted) of the (redacted). The (redacted) monitoring device that reads to the (redacted) chart is attached to the outside surface of the (redacted). They did not determine if the installation locations of their (redacted) and recording devices provide an accurate reading of the (redacted) during operating conditions.

Current Good Manufacturing Practice (Subpart B)

  1. The firm did not take adequate precautions to ensure that production procedures did not contribute to allergen cross-contact. Specifically, on Dec. 14, 2021, employees were observed first assembling Protein Powerhouse Snacker which includes hard-cooked egg, red grapes, and cheddar cheese cubes (among other ingredients). Individual ingredients were staged in bins on the (redacted) Line. (Redacted) placed hard-cooked egg, red grapes, and cheddar cheese cubes from the bins into finished product trays using the same (redacted). The same bins of red grapes and cheddar cheese cubes were then used to assemble Apple & Cheese Snacker and subsequently Fruit & Cheese Snacker, neither of which contains egg. Additionally, on Dec. 20, 2021, investigators observed a bin of dried cranberries that contained several soybeans. Their employees stated the cranberries were staged to be used in Super Kale Salad that did not contain soy.

The full warning letter can be viewed here.

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