As part of its enforcement activities, the Food and Drug Administration sends warnings to entities under its jurisdiction. Some letters are not posted for public viewing until weeks or months after they are sent. Business owners have 15 days to respond to the FDA’s warning letters. Warning letters are often not issued until a company has been given months to years to correct the problems.
Reconserve Inc.
Santa Monica, CA
A California food company with a facility in Maryland is on notice from the FDA for unsanitary storage of ingredients that could contaminate food products. A Jan. 3, 2024, the warning letter serves as a reminder that pet food products may contain dangerous pathogens and should be handled as carefully as other products.
In the warning letter, the FDA described a May 23 to June 29, 2023, inspection of Reconserve Inc.’s animal food manufacturing facility. in Baltimore, MD.
The FDA inspection was in response to a complaint from a state regulatory partner about the ingredient’s storage conditions.
During the inspection, an FDA Investigator found evidence of significant violations of Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Animal Food, which caused the company’s products to be adulterated. Additionally, this inspection found evidence that their product was adulterated in whole or in part with an impure, rotten or decaying substance.
After the inspection, FDA investigators issue 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 company’s animal feed facility is subject to CGMP requirements. During the inspection of their facility, FDA Investigators found evidence of significant violations of these requirements, which included:
1. The company did not test their raw materials and other ingredients to ensure they were suitable for manufacturing and processing animal feed, and they did not handle them under conditions that would protect against contamination and reduce damage if necessary.
Specifically, on May 23, 2023, FDA Investigators observed human food bakery products intended for use as an ingredient in their (redacted) outside, piled in gravel and uncovered. They said they began storing received ingredients there in February 2023, after a fire occurred at their facility. The FDA Investigator observed the visual state of these substances that had deteriorated and contained foreign materials such as: gravel, rock, soil, mud, unidentifiable substances and unknown man-made foreign materials. The FDA Investigator also observed wild birds flying, landing and feeding on the pile, and insects flying and crawling on the pile. The pile is exposed to contamination from weather conditions including rainfall, and runoff of rainwater containing chemicals from nearby trucks and industrial equipment. The company’s Vice President of Environmental Health and Safety estimated this outside storage pile of ingredients (redacted) and the facility (redacted) of ingredients from the storage pile with newly received ingredients to make animal feed.
2. The firm did not effectively protect animal feed stored outside in bulk from contamination, including (1) use of protective covers when necessary and appropriate; (2) controlling areas on and around bulk animal feedlots to eliminate harborages for pests; and (3) regular testing for pests, pest infestations, and product conditions related to food animal safety, as necessary.
Specifically, on May 23, 2023, and June 7, 2023, FDA Investigators observed an uncovered pile of human food bakery products intended for use in their (redacted) which is stored outdoors directly on an uncovered gravel driveway in their facility. The FDA Investigator observed wild birds flying, landing, and feeding on the pile; flying and crawling insects; broken packaging materials and foreign matter such as gravel, rock, soil, mud, and other unknown man-made material mixed into the pile. In addition, it was discovered that bakery by-products had been exposed to contamination since Feb. 2023 from weather conditions such as precipitation and runoff from rainwater and waste from birds, insects, and rodents. The pile is about three feet high and (redacted) in size and composed of (redacted) of bakery products.
3. frim does not maintain the grounds around their feed plant under their control in a condition that will protect against contamination of the feed, including maintaining the grounds to properly store equipment and remove trash and debris within the immediate vicinity of the plant that may serve as an attractant, breeding ground, or harborage for pests, as necessary.
Specifically, on May 24, 2023, and June 7, 2023, FDA Investigators observed discarded metal utensils, burned metal barrels, wood pallets, plastic packaging materials, and other waste stored outside the walls of the manufacturing facility which can be an attractant. , breeding place, or prison of pests.
Requirements for Hazard Analysis and Risk-Based Preventive Controls
The company’s animal feed facility is subject to risk analysis and risk-based containment requirements. During the inspection of their facility, FDA Investigators found evidence of significant violations of these requirements, which included:
4. The company did not conduct a hazard analysis to identify and evaluate, based on experience, disease data, scientific reports, and other information, known or reasonably foreseeable risks for each type of animal food produced, processed , packed, or held in their facility to determine if there are any hazards that require a preventive control, if necessary.
Specifically, in February 2023, the company began stocking human food bakery products intended for use as an ingredient in their (redacted) outside, piled directly on a gravel ground and uncovered. They have not identified or evaluated the risks associated with the change in their process of storing these materials outside and exposed to the environment. Known or reasonably foreseeable risks include, but are not limited to:
A. Pests such as birds, rats, and insects
B. Packaging materials (plastic and cardboard)
C. Foreign objects, including but not limited to, gravel, rock, soil, mud, metal, and unknown man-made foreign materials
D. Chemicals such as lubricants and coolants from trucks parked next to the pile and from nearby vehicular traffic
E. Malnutrition
F. Unknown industrial chemicals from this and neighboring facilities
In addition, they did not identify and evaluate the known or reasonably foreseeable risk of recontamination of environmental pathogens in the processing steps following the dryer, which they identified as their control for pathogens in their ingredients.
5. The company has not demonstrated that the preventive control process they have identified and implemented is adequate to control the risk appropriate to the nature of the preventive control and its role in their facility’s food safety system, if necessary.
The company’s risk assessment for (redacted) documenting a CCP (critical control point) in the dryer step to control pathogens, which they identified as a hazard requiring preventive control. Their hazard analysis states that they operate the dryer at an “average temperature of (redacted)” for at least (redacted). However, they failed to prove the use of their dryer as a preventive control to significantly reduce or eliminate pathogens in their (redacted). For example, they have not provided any scientific or technical evidence or studies that determine whether the dryer works (redacted) at the lowest of (redacted) is sufficient to control pathogens, if necessary.
6. The firm failed to establish and implement written procedures for monitoring their preventive controls, as required. In addition, they failed to document monitoring of containment controls, as required. “Monitoring” means to carry out a planned sequence of observations or measurements to assess whether control measures are working as intended.
The company’s risk assessment for (redacted) a preventive control process is identified in the “Dryer” step. They do not have written procedures for monitoring preventive control that outline the parameters to be controlled in the dryer step (eg, temperature and time), the maximum and minimum values for the parameters, and the frequency at which monitor these parameters. . Additionally, they did not provide documentation of any monitoring activities related to their preventive control in the dryer step, such as temperature records, to demonstrate that these activities were ongoing.
The full warning letter can be viewed here.
(To sign up for a free subscription to Food Safety News, press here.)
