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  5. ReConserve Inc. - 663413 - 01/03/2024
  1. Warning Letters

WARNING LETTER

ReConserve Inc. MARCS-CMS 663413 —

Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Food & Beverages
Recipient:
Recipient Name
Mr. David Luskin
Recipient Title
President
ReConserve Inc.

2811 Wilshire Blvd. Suite 410
Santa Monica, CA 90403
United States

Issuing Office:
Division of Human and Animal Food Operations East II

United States

Secondary Issuing Offices

United States

WARNING LETTER
CMS #663413

January 03, 2024

Dear Mr. Luskin,

The U.S. Food and Drug Administration (FDA) conducted an inspection of your animal food manufacturing facility located at 3220 Sun Street, Baltimore, MD 21226, from May 23 through June 29, 2023, 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 requirements in Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507), which cause your products to be adulterated.1 Additionally, this inspection found evidence that your product is adulterated because it consists in whole or in part of a filthy, putrid, or decomposed substance.2 The introduction or delivery for introduction into interstate commerce of any food that has been adulterated is a prohibited act.3 Also, the failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of 21 CFR Part 507 is a prohibited act.4

You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.

At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your written response, dated July 14, 2023. We have reviewed your response and address your corrective actions below in relation to each of the noted violations.

Current Good Manufacturing Practice (CGMP) Requirements for Animal Food

Your animal food facility is subject to the CGMP requirements found in 21 CFR Part 507, subparts A, B, and F. During the inspection of your facility, the FDA Investigator observed evidence of significant violations of these requirements, which included:

1. You did not examine your raw materials and other ingredients to ensure they were suitable for manufacturing and processing into animal food, and you did not handle them under conditions that will protect against contamination and minimize deterioration as required by 21 CFR 507.25(b)(1).

Specifically, on May 23, 2023, the FDA Investigator observed human food bakery by-products intended for use as an ingredient in your (b)(4) outside, piled on a gravel ground and uncovered. You stated that you started storing these received ingredients there around February 2023, after a fire occurred at your 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. Your Vice President of Environmental Health and Safety estimated this outdoor storage pile of ingredients to be (b)(4) and the facility (b)(4) of ingredients from this storage pile with newly received ingredients to manufacture animal food.

Evaluation of your response:
Your firm’s response states your manufacturing process is designed to remove foreign material and the color difference in the ingredients stored outside from ingredients stored inside is due to chocolate products being mixed into only the outdoor pile. During the inspection, your firm was informed of FDA’s concerns that the outdoor ingredient pile was unfit for food and that FDA considered the outdoor ingredient pile to be adulterated due to the observed conditions of the ingredients and pest activity. After this discussion, your firm ceased using the outdoor pile of ingredients on June 1, 2023, however, you resumed using these ingredients in your (b)(4) on June 21, 2023, without conducting an evaluation to determine if the ingredients were fit for food. Your response is inadequate because it does not address FDA’s concerns regarding the deteriorated and contaminated state of the ingredients stored outside on the ground and uncovered. As a manufacturer of animal food, you are responsible for ensuring the animal food you introduce into interstate commerce is not adulterated, including complying with the CGMP requirements of Part 507.

2. You 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 by 21 CFR 507.17(c).

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 your (b)(4) being stored outside directly on an uncovered gravel driveway at your 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 February 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 (b)(4) in size and consisted of (b)(4) of bakery by-products.

Evaluation of your response:
In your firm’s response, you state your system is designed to remove packing and other foreign materials and render sterile any contaminants from pests so that they do not pose a threat to animal health “as demonstrated by our never having made an animal sick in the history of our company.” You have not provided supporting evidence that your system is capable of sterilizing the product. Furthermore, your response does not sufficiently address other animal food safety hazards that could result from the observed storage conditions, such as: nutrient degradation, contamination with toxins from mold formation, or contamination from chemical hazards and physical hazards (e.g., gravel).

In addition, your response states you will develop and use an inspection form to document the storage conditions of raw material ingredients no later than July 24, 2023. You did not provide records or other information that would allow FDA to evaluate the adequacy of your correction. We encourage you to provide documentation of your corrective actions in follow-up correspondence.

3. You did not keep the grounds around your animal food plant under your 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 required by 21 CFR 507.17(a)(1).

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.

Evaluation of your response:
Your written response states the area in question has since been cleaned and put in an orderly fashion to allow for the safe storage of materials outside. However, you did not provide any photographs, records, or other evidence of your correction. Therefore, we are unable to evaluate the adequacy of your response. We encourage you to provide documentation of your corrective actions in follow-up correspondence.

Hazard Analysis and Risk-Based Preventive Controls Requirements

Your animal food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During the inspection of your facility, the FDA Investigator observed evidence of significant violations of these requirements, which included:

4. You 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 your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 507.33(a).

Specifically, in February 2023, you began storing human food bakery by-products intended for use as an ingredient in your (b)(4) outside, piled directly on a gravel ground and uncovered. You did not identify or evaluate hazards associated with the change in your 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, you did not identify and evaluate the known or reasonably foreseeable hazard of recontamination with environmental pathogens in the processing steps following the dryer, which you have identified as your control for pathogens in your ingredients.

Evaluation of your response:
In your written response, it states the “Receiving” step of your hazard analysis and critical control points (HACCP) plan applies to all materials in the receiving area, including materials stored outside of the covered storage area. However, your hazard analysis does not make any reference to outdoor storage and does not consider hazards that may occur from excessive exposure to the environment. You did not present any records for review to document these hazards were considered. Therefore, we are unable to evaluate the adequacy of your response.

5. You did not validate that the process preventive control you identified and implemented in accordance with 21 CFR 507.34 is adequate to control the hazard as appropriate to the nature of the preventive control and its role in your facility’s food safety system, as required by 21 CFR 507.47(a).

Your hazard analysis for (b)(4) documents a CCP (critical control point) at the dryer step to control pathogens, which you determined are a hazard requiring a preventive control. Your hazard analysis states that you operate the dryer at an “average temperature of (b)(4)” for a minimum of (b)(4).5 However, you failed to validate the use of your dryer as a preventive control to significantly minimize or eliminate pathogens in your (b)(4). For example, you were unable to provide any scientific or technical evidence or studies that determined whether the dryer operating at (b)(4) at a minimum of (b)(4) would be adequate to control pathogens, as required by 21 CFR 507.47(b)(2).

Evaluation of your response:
In your written response you discussed the preliminary results of your study to confirm the time it takes for material to pass through the dryer, your plans to continue the study, and intent to update your HACCP Plan after you gathered additional data. You also provided laboratory analysis reports from a 3rd party laboratory for samples your firm collected after the drying step for an unspecified lot(s) of your (b)(4). These samples were received by the laboratory on June 29, 2023. We acknowledge the analytical results do not report detectable levels of bacteria including Escherichia coli (generic), Salmonella spp., and Listeria spp., and are below detectable limits for mycotoxins. However, your study appears to be based on a single set of analytical data. This is not a sufficient representation of the tonnage for the products you manufacture, and it is unclear what the starting pathogen load was prior to the lot being processed through your dryer step. You have not submitted scientific and technical evidence, or a validation study that demonstrates your process control at the dryer step will effectively control the pathogen hazard. We are therefore unable to determine the adequacy of your response.

6. You failed to establish and implement written procedures for monitoring your preventive controls, as required by 507.40(a). In addition, you failed to document the monitoring of preventive controls, as required by 21 CFR 507.40(c)(1). “Monitoring” means to conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended.6

Your hazard analysis for (b)(4) identifies a process preventive control at the “Dryer” step. You 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, you did not provide documentation of any monitoring activities related to your preventive control at the dryer step, such as temperature records, to demonstrate that these activities consistently took place.

Evaluation of your response:
We are unable to evaluate your response since it did not include evidence that you have established and implemented procedures for monitoring your “Dryer” preventive control, including documenting your monitoring activities.

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal action, including without limitation, seizure, and injunction.

We also have the following comment:

In February 2023, you began storing human food bakery by-product ingredients intended for further processing outdoors directly on an uncovered gravel driveway at your facility. Your hazard analysis does not address this change in your storage activities, and you did not present records to document that you performed a reanalysis of your food safety plan. In your response dated July 14, 2023, you indicate that you will conduct an annual review of your plan in October 2023. We encourage you to provide documentation of this annual review in follow-up correspondence. You must conduct a reanalysis of your food safety plan as a whole at least once every three years. In addition, you must conduct a reanalysis of your food safety plan as a whole, or the applicable portion of the food safety plan, whenever a significant change in the activities conducted at your facility creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard (21 CFR 507.50).

For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:

  • Guidance for Industry #235: “Current Good Manufacturing Practice Requirements for Food for Animals” https://www.fda.gov/media/97464/download
  • Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” https://www.fda.gov/media/110477/download
  • Draft Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program” https://www.fda.gov/media/113923/download

Within fifteen (15) working days of the receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the timeframe within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

Please send your written response to Compliance Officer Daniel W. Johnson at U.S. Food & Drug Administration, 200 Chestnut Street, Room 900, Philadelphia, Pennsylvania 19106. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact Daniel W. Johnson by telephone at (215)-717-3746 or by email at Daniel.Johnson@fda.hhs.gov.

Sincerely
/S/

Randy F. Pack
Program Division Director
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
randy.pack@fda.hhs.gov

Cc: Keith D. Rudd, Vice President of Environmental Health and Safety
ReConserve of Maryland via email to KRudd@reconserve.com

________________________

1 See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).

2 See Section 402(a)(3) of the FD&C Act [21 U.S.C. § 342(a)(3)].

3 See Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

4 See Section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].

5 During the inspection close-out meeting on June 29, 2023, the firm’s Vice President of Environmental Health and Safety informed the FDA Investigator that there is an error on the firm’s written HACCP Plan and their dryer processing step should read “dryer runs at an average temperature of (b)(4). Material is on the dryer for a minimum of (b)(4) at that temperature” instead of (b)(4).

6 See 21 CFR 507.3

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