FDA issues warning letters to cereal, CBD companies

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.

California Cereal Products — Macon, GA
The Food and Drug Administration sent a warning letter dated Nov. 19, 2019, to Co-founder and Ceo of California Cereal Products, Robert Savely.

During an inspection at Califonia Cereal Products facility from July 8-11, 2019, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. The warning letter says that, “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, 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.”

In response to these deviations, the FDA issued an FDA 483, Inspectional Observations that lists deviations observed at the facility.

The violations noted by the FDA:

“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.”

“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 (redacted), 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.”

“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.”

“Mill (redacted) 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 (redacted) (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 (redacted) 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.”

“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 (redacted) 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 (redacted) 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 (redacted) flavor tank (redacted). This tank is used to make flavors added to the cooking step of cereal production and was in use during the inspection.”

“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.”

A complete list of the violations can be found in the FDA’s warning letter.

Organix Industries Inc. dba Plant Organix — San Bernardino, CA

The Food and Drug Administration sent a warning letter dated Nov. 22, 2019, to Ms. Thibodeaux of Organix Industries, Inc. dba Plant Organix.

In Oct. 2019, the FDA reviewed Plant Organix’s website at and determined that the company takes orders for food products that are marketed as unapproved drugs and sold in violation of federal law.

The listed products are:

Classic Peanut Butter 300 mg CBD
CBD Hibiscus Tea
Banana Chips 300 mg CBD
Kiwi 300 mg CBD
Pineapple 300 mg CBD
Mango 300 mg CBD
Chili Mango 300 mg CBD
Apple Rings Gummies
Watermelon Sours Gummies
Sour Brats Gummies
Peach Rings Gummies
Gummy Bears Gummies
Pain Roll – Pain Oil
CBD Sleep Tincture
Meraki Intense Pain Balm/Lidocaine
Meraki Lotion
Meraki Lip Balm
Meraki Pain Salve (500mg and 1000mg versions),
Natural Tincture
CBD Tincture (aka “MCT Oil Tincture”),

Products containing cannabidiol (CBD)

FDA has also determined that the following products are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5):

Hemp Pet Tinctures
Hemp Pet Treats

FDA also determined that the following products are adulterated under Section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive:

Banana Chips 300mg CBD
Mango 300mg CBD
Chili Mango 300mg CBD
Kiwi 300mg CBD
Classic Peanut Butter
CBD Hibiscus Tea
Apple Rings Gummies
Watermelon Sours Gummies
Sour Brats Gummies
Gummy Bears Gummies
Peach Rings Gummies
Pineapple 300mg CBD

Lastly, the FDA determined that it is a prohibited act to introduce the following products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll):