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RESPONSE LETTER

California Cereal Products


Reference #:
590804

Company:
California Cereal Products

4375 Mead Road
Macon, GA 31206
United States

478-784-3440
Recipient:

United States


CALIFORNIA CEREAL PRODUCTS
4375 MEAD ROAD
MACON, GEORGIA 31206
478-784-3440   478-784-3413 FAX
californiacereal@msn.com

December 6, 2019

OVERNIGHT VIA FEDERAL EXPRESS

EMAILED TO ORAATL483RESPONSE@FDA.HHS.GOV

EMAILED RO PATRICIA.HUDSON@FDA.HHS.GOV

Patricia F. Hudson
Compliance Officer, U.S. Food and Drug Administration
60 8th Street, NE
Atlanta, GA 30309

Response: to CMS Case # 590804

FDA Observations

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. 

California Cereal products (CCP) Response,

The term "throughout your manufacturing facility" is not totally accurate. The plant is (b)(4) in size. The problem was confined to three small areas, the Proof Room ((b)(4)), the Mill Room ((b)(4)) and the Trash Compacting Room ((b)(4)). These three areas represent (b)(4) of the plant's square footage.

Specifically:

FDA Observation Ten plus (10+) live flying and ten plus 0+) 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.

CCP Response: There is no excuse for the condition that the auditor found in the mill room. We would like to point out that Dryer (b)(4) is three feet above the floor. Residence time of the product is (b)(4)

CCP Corrective Action: At the time of the inspection we had (b)(4) Georgia State licensed pest control operator. Today we have (b)(4), with the express mission of eliminating these issues, The mill room now has its own designated sanitation person (b)(4). The blowers are being raised 4" off the floor to enable easier cleaning, (b)(4).

FDA Observation: 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 o f#4 medium rolled oats, lot 41903178. The insects were also observed inside one of the 50-lb. bags. The bag was staged for production.

CCP Response: The bags were not staged for production. The (b)(4) of oats were to be used (b)(4) on our (b)(4). They were never intended for consumption. This product had been received 12 days earlier and we believe it arrived infested, The room also contained over (b)(4) of rice, none of which, was infested. All grains are cooked in a manner that results in a (b)(4).

CCP Corrective Action: At the time of the inspection we had (b)(4) Georgia State licensed pest control operator. Today we have (b)(4), with the express mission of eliminating these issues. Our Inbound Trailer Inspection Checklist has been modified from "Did you find any evidence of rodent activity" to 'Did you find any evidence of infestation or rodent activity'.

FDA Observation: 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.

CCP Response: This room is segregated from the rest of the plant. The root cause was a slow draining 3" floor drain which inhibited proper cleaning of the trash compactor room. The drain was found to be partially collapsed in a location that could not be repaired. The rollup door to the trash compactor room is only supposed to be opened at the end of each shift in order for the operators to insert their Human Food By-Product modules. The door is then closed. 

CCP Corrective Actions: At the time of the inspection we had (b)(4) Georgia State licensed pest control operator. Today we have (b)(4), with the express mission of eliminating these issues. We filled the 3" floor drain with concrete and replaced it with a 10' x 5" trench drain. We then installed a 140 foot line to the nearest grease trap. The trash compactor room now has a full time sanitation person on first shift. The rollup door now has a lock. The area that had standing water has been sloped so water now flows into the trench drain, The trash compactor room now has its own dedicated pressure washer. The rough floors are being addressed and (b)(4). The trash compactor room SOP has been updated to include the time restraints on opening the internal roll up door; also only authorized personnel will have a key to open the roll up door. The trash compactor room cleaning policy has been revised to include the new pressure washer and trench drain. The frequency of cleaning the trash compactor room has been increased on the Master Sanitation schedule.

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,

FDA Observation: 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.

CCP Response: The temperature difference between the chilled water system and the warmer ambient air caused water droplets to condense on the pipes above the metal frame holding the mills.

CCP Corrective Action: All of the pipes containing chilled water have since been insulated. No water droplets have been observed since the modification. The mill start-up procedures have been modified so that chilled water is only introduced to the rolls when product is flowing.

FDA Observation: 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.

CCP Response: A water discharge line for the air handler was clogged.

CCP Corrective Action: The air handler drain lines have been rerouted away from roof penetrations and all roof penetrations have been resealed, No water droplets have been observed since the modifications.

FDA Observation: 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.

CCP Response: Elbows, valve handles and supports had not been insulated.

CCP Corrective Action: All elbows, valve handles and supports have been insulated. No water droplets have been observed since the modification.

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:

FDA Observation: 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.

CCP Response: The purpose of this sampling was to determine the feed rate, in pounds per minute, going through the mills.

CCP Corrective Action This procedure has been eliminated. Variable speed drives have been installed on the mill feed screws. The numbers on the drive's dials are calibrated to equal pounds per minute. The operator now has to simply set the dial to the desired feed rate. There is no longer a need to introduce a container into the food stream.

FDA Observation: 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.

CCP Corrective Action: The bucket elevator has been raised. The buckets are now suspended approximately 13" above the floor. Directly underneath the buckets is a stainless steel, removable, catch pan. This catch pan is 7" above the floor and can be easily cleaned.

FDA Observation: 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

CCP Response: The discoloration was not rust, but caramel color.

CCP Corrective Action: The blades were removed and cleaned. The rough weld has been ground smooth. The surface is now easily cleaned. A run-length risk assessment has been completed for the mixer; the cleaning frequency has been revised and added to the production cleaning schedule.

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.

CCP Corrective Action: All loose tiles have been replaced. The remaining tiles are in good repair and can be adequately cleaned. We have started to replace all of the tiles with concrete, but as fate would have it, they don't want to come up. Because of the time involved in removing the tiles we are having to do it in sections. These remaining tiles are good and cleanable, we have just chosen to go to concrete.

Sincerely
/S/
Robert S. Savely
C.E.O, California Cereal products, Inc.