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.
Santa Monica, CA
A California food firm with a facility in Maryland is on notice from the FDA for unsanitary storing of ingredients that could contaminate food products. A Jan. 3, 2024, warning letter serves as a reminder that pet food products can contain dangerous pathogens and should be handled as carefully as other products.
In the warning letter, the FDA described a May 23 through June 29, 2023, inspection of Reconserve Inc.’s animal food manufacturing facility in Baltimore, MD.
The FDA’s inspection was in response to a complaint from a state regulatory partner about ingredient storage conditions.
During the inspection, an FDA Investigator found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, which caused the firm’s products to be adulterated. Additionally, this inspection found evidence that their product is adulterated in whole or in part because of a filthy, putrid or decomposed substance.
After the inspection, FDA investigators issued a Form 483 (FDA-483), Inspectional Observations.
Some of the significant violations are as follows:
Current Good Manufacturing Practice (CGMP) Requirements for Animal Food
The firm’s animal food facility is subject to the CGMP requirements. During the inspection of their facility, the FDA Investigator observed evidence of significant violations of these requirements, which included:
1. The firm did not examine their raw materials and other ingredients to ensure they were suitable for manufacturing and processing into animal food, and they did not handle them under conditions that will protect against contamination and minimize deterioration as required.
Specifically, on May 23, 2023, the FDA Investigator observed human food bakery by-products intended for use as an ingredient in their (redacted) outside, piled on a gravel ground and uncovered. They stated that they started storing these received ingredients there around February 2023, after a fire occurred at their facility. The FDA Investigator observed the visual state of these ingredients to be deteriorated and containing foreign material such as: gravel, rocks, soil, mud, unidentifiable substances and unknown man-made foreign materials. The FDA Investigator also observed wild birds flying around, landing and feeding on the pile, and insects flying around and crawling on the pile. The pile is exposed to contaminations from weather conditions including rainfall, and rainwater runoff with chemicals from nearby trucks and industrial equipment. The firm’s Vice President of Environmental Health and Safety estimated this outdoor storage pile of ingredients to be (redacted) and the facility (redacted) of ingredients from this storage pile with newly received ingredients to manufacture animal food.
2. The firm did not effectively protect the animal food stored outdoors in bulk from contamination, including by (1) using protective coverings where necessary and appropriate; (2) controlling areas over and around the bulk animal food to eliminate harborages for pests; and (3) checking on a regular basis for pests, pest infestation, and product condition related to safety of the animal food, as required.
Specifically, on May 23, 2023, and June 7, 2023, the FDA Investigator observed an uncovered pile of human food bakery by-products intended for use in their (redacted) being stored outside directly on an uncovered gravel driveway at their facility. The FDA Investigator observed wild birds flying, landing, and feeding upon the pile; flying and crawling insects; deteriorated packaging materials and foreign objects such as gravel, rocks, soil, mud, and other unknown man-made materials mixed in the pile. In addition, the uncovered bakery by-products were exposed to contamination since Feb. 2023 from weather conditions such as rainfall and rainwater runoff and excreta from birds, insects, and rodents. The pile was approximately three feet high and (redacted) in size and consisted of (redacted) of bakery by-products.
3. The frim did not keep the grounds around their animal food plant under their control in a condition that would protect against the contamination of animal food, including maintenance of grounds to properly store equipment and remove litter and waste within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests, as require.
Specifically, on May 24, 2023, and June 7, 2023, the FDA Investigator observed discarded metal equipment, burned metal barrels, wood pallets, plastic packaging materials, and other trash stored against the outside wall of the manufacturing facility that may constitute an attractant, breeding place, or harborage for pests.
Hazard Analysis and Risk-Based Preventive Controls Requirements
The firm’s animal food facility is subject to the hazard analysis and risk-based preventive controls requirements. During the inspection of their facility, the FDA Investigator observed evidence of significant violations of these requirements, which included:
4. The firm did not conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control, as required.
Specifically, in February 2023, the firm began storing human food bakery by-products intended for use as an ingredient in their (redacted) outside, piled directly on a gravel ground and uncovered. They did not identify or evaluate hazards associated with the change in their process of storing these materials outside and exposed to the environment. Known or reasonably foreseeable hazards include, but are not limited to:
A. Pests such as wild birds, rodents, and insects
B. Packaging materials (plastic and cardboard)
C. Foreign objects, including but not limited to, gravel, rocks, soil, mud, metal, and unknown man-made foreign materials
D. Chemicals such as lubricants and coolants from trucks parked adjacent to the pile and from nearby vehicle traffic
E. Nutrient deficiencies
F. Unknown industrial chemicals from this and neighboring facilities
In addition, they did not identify and evaluate the known or reasonably foreseeable hazard of recontamination with environmental pathogens in the processing steps following the dryer, which they have identified as their control for pathogens in their ingredients.
5. The firm did not validate that the process preventive control they identified and implemented is adequate to control the hazard as appropriate to the nature of the preventive control and its role in their facility’s food safety system, as required.
The firm’s hazard analysis for (redacted) documents a CCP (critical control point) at the dryer step to control pathogens, which they determined are a hazard requiring a preventive control. Their hazard analysis states that they operate the dryer at an “average temperature of (redacted)” for a minimum of (redacted). However, they failed to validate the use of their dryer as a preventive control to significantly minimize or eliminate pathogens in their (redacted). For example, they were unable to provide any scientific or technical evidence or studies that determined whether the dryer operating at (redacted) at a minimum of (redacted) would be adequate to control pathogens, as required.
6. The firm failed to establish and implement written procedures for monitoring their preventive controls, as required. In addition, they failed to document the monitoring of preventive controls, as required. “Monitoring” means to conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended.
The firm’s hazard analysis for (redacted) identifies a process preventive control at the “Dryer” step. They do not have written procedures for monitoring the preventive control that outline the parameters that must be controlled at the dryer step (e.g., temperature and time), the maximum and minimum values for the parameters, and the frequency with which these parameters must be monitored. Additionally, they did not provide documentation of any monitoring activities related to their preventive control at the dryer step, such as temperature records, to demonstrate that these activities consistently took place.
The full warning letter can be viewed here.
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