WARNING LETTER

California Cereal Products MARCS-CMS 590804 — November 19, 2019

Delivery Method:: UPS Overnight Delivery
Product:: Food & Beverages
Cereal/Breakfast Food

Recipient:: Recipient Name

Robert Sterling Savely; Recipient Title

Co-Founder, Chairman, CEO/CFO; California Cereal Products; 4375 Mead Road
Macon, GA 31206-1946
United States

Issuing Office:: United States

WARNING LETTER

November 19, 2019

Reference: CMS Case # 590804

Dear Mr. Savely:

The United States Food and Drug Administration (FDA) inspected your dry cereal manufacturing facility, located at 4375 Mead Road, Macon, GA from July 8 – 11, 2019. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

Based on FDA’s inspectional findings, we determined that the dry cereal products manufactured in your facility are 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)], in that they have been prepared packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and FDA regulations through links on FDA’s homepage at www.fda.gov.

At the conclusion of the inspection, FDA issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. Although you made some corrective actions during the inspection, we have not received a response to inspectional observations that were not corrected except for photographs showing a partial correction to the production floor. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

We found the following significant violations:

1. You did not take effective measures to exclude pests from your food plant to protect against contamination of food, as required by 21 CFR § 117.35(c).

During the inspection on July 8 and 9, 2019, the FDA investigator noted evidence of live insect activity throughout your manufacturing facility, including the trash compacting area which was directly open to the production area where cereal products are manufactured.
Specifically,

• Ten plus (10+) live flying and ten plus (10+) live beetle type insects were observed in the mill room, where post cook step activities occur. Insect trails and live beetle type insects too numerous to count were observed beneath dryer (b)(4), and live beetle type insects too numerous to count were observed beneath the framework of the blower used to transfer the cooked cereal products.

• In the ingredient storage/staging area, approximately fifteen (15) live beetle-type insects were observed between the plastic overwrap and exterior of the paper package of 50-lb. bags of #4 medium rolled oats, lot #1903178. The insects were also observed inside one of the 50-lb. bags. The bag was staged for production.

• Approximately twenty (20) live flying insects and live beetle-type insects too numerous to count were observed on, in, and around an approximate 1-foot x 2-foot area that appeared to be old wet product residues on the floor beneath the trash compactor.

• The floor area beneath the trailer parked below the trash compactor was observed with at least four (4) live American-type cockroaches. Approximately twenty plus (20+) live flying insects and live beetle type insects were also noted in this area on, in, and around substances that appeared to be old wet product residues on the floor. The concrete floor in this area is heavily worn and not easily cleanable.

• An approximate 3-foot x 2-foot area of standing, soiled water containing live insect larvae was observed in the worn concrete floor between the trailer and steps leading back up to the trash compactor. This area was also observed to have ten plus (10+) flying insects.

During the inspection, you voluntarily destroyed the 50-lb. bags of rolled oats and cleaned the processing and auxiliary areas to remove the insect activity. In addition, you closed the rollup door which separates the trash compactor area from production. However, you have not submitted a written response outlining corrective actions that will be implemented and sustainable to prevent the ingress of pest activity into your food facility.

2. Your plant was not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR § 117.20(b)(4).

During the inspection, the investigator noted multiple instances of condensate dripping onto food contact surfaces or exposed product. Specifically,

• Mill (b)(4) in the mill room was observed with condensate dripping from the drum rollers onto the rusted metal framework below and above the open product zone. Water condensate from the rollers on both mill (b)(4) (used to flatten rice into rice crisps) was observed falling onto the floor and standing in puddles beneath the mills.

• The air handling unit located in the ceiling at the end of dryer (b)(4) in the mill room, adjacent to the bucket elevator and supersack fill station, was observed dripping water onto the floor in this area where product is exposed.

• Chill water lines throughout the mill room were observed with condensate forming and dripping at each connection point in the line onto the floor below.

3. Your equipment and utensils were not adequately maintained to protect against allergen cross-contact and contamination, as required by 21 CFR §117.40(a)(1). Specifically, our investigator observed the following:

• A mill room employee collecting an in-line sample of brown rice crisps placed a white plastic bucket into the hoppers adjacent to mill (b)(4) in direct contact with the product. The employee used white plastic scoops that were stored on a table in direct contact with non-food contact items to scoop a sample from the bucket, returned the contents of the scoop to the bucket, then emptied the bucket back into the product stream after your firm’s thermal kill step.

During the inspection, the plastic bucket was replaced with a smaller aluminum pitcher and your maintenance manager stated the sampled product will be destroyed in lieu of introducing it back into the product stream. However, your corrective action did not address the manner in which the sampling utensils and container are maintained during production in that these food contact surfaces are placed into direct contact with insanitary items such as an unclean table surface.

• The bucket elevator on dryer (b)(4) in the mill room is designed so that it is within one half inch of the floor. During the inspection, the buckets were observed in direct contact with overflowed product on the floor.

During the inspection, you stated employees can clean the floor area more frequently to prevent the bucket elevator from traveling through the product. However, you have not submitted a written response outlining corrective actions that will be implemented to address this deficiency and measures that will be taken to prevent its recurrence.

• Our investigator observed the accumulation of apparent rust adhering to the dasher blades and a rough weld on the seam of the bottom of the dasher blade in the (b)(4) flavor tank (b)(4). This tank is used to make flavors added to the cooking step of cereal production and was in use during the inspection.

4. You did not construct the plant floors in a manner that may be adequately cleaned, kept clean, and in good repair as required by 21 CFR §117.20(b)(4). Specifically, the investigator observed an approximate 18-inch x 16-inch area of broken tiles in the cook area of the production floor on the west side of the discharge belt that suspends from the cookers; the floor of this area was observed with standing, discolored water. In the same general area of the production floor, an approximate 24-inch x 24-inch area was observed with broken tiles that were jagged and not easily cleanable.

During the inspection, your maintenance manager stated that the floor was scheduled to be repaired and replaced with a smooth epoxy-coated surface. We received your response from August 1, 2019, with photographs showing that the floor tiles had been repaired for one of the areas cited on the FDA 483. However, you have not submitted a response showing the replacement of the entire floor.

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws and regulations. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and/or injunction. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

Although not covered during this inspection, you are subject to the preventive control requirements (primarily located in subparts C and G) of the CGMP & PC rule. Under those requirements, a covered food facility must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 USC §§ 342 and 343(w)). Further, a covered food facility must have a written food safety plan that includes a written hazard analysis and written preventive controls that are appropriate to the facility and food (i.e., process controls, food allergen controls, sanitation controls, recall plan, and a supply chain program as necessary). Other requirements include employee training (subpart A) and recordkeeping (subpart F). Exemptions (21 CFR 117.5) and modified requirements (subpart D) are applicable to certain operations.

Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially

related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

To date we have not received a written response from you outlining corrective actions to address the violations identified during the inspection. Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, and other useful information that would assist us in evaluating your corrections. If the corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Your written response should be sent to Patricia F. Hudson, Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, NE, Atlanta, GA 30309. If you have any questions regarding the content of this letter, please contact Patricia F. Hudson at 404-253-2221 or email at patricia.hudson@fda.hhs.gov.

Sincerely,
/S/

Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Food Operations – East Division 3

Cc:

Natalie Adan, Division Director
Food Safety Division
Georgia Department of Agriculture
19 Martin Luther King, Jr. Dr. S.W.
Atlanta, GA 30034