| Public Health Service Food and Drug Administration |
Los Angeles District 19701 Fairchild Irvine, California 92612-2506 Telephone (949) 608-2900 Fax: (949) 608-4415 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
February 16, 2011
W/L 27-11
Ms. Amy E. Grawitsky, President
Mave Enterprises, Inc.
11555 Cantara St. Ste B-E
North Hollywood, CA 91605-1652
Dear Ms. Grawitsky:
The Food and Drug Administration (FDA) conducted an inspection of your food storage and processing facility, located at 11555 Cantara St. Ste B-E, North Hollywood, California, from September 27 through October 05, 2010. During the inspection, FDA investigators documented serious violations of FDA’s Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These conditions cause the foods stored at your facility, including but not limited to, dry fruit, spices, bubble gum, chocolate, and other candy, to be 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)] because these food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
The following violations were observed during the inspection:
1) You failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). For example, our inspector observed:
• On both September 27 and 28, 2010, rodent-like excreta pellets were in close proximity to stored food products in various locations throughout Unit E. More specifically, rodent excreta was located:
o On a wooden pallet adjacent to the south wall and approximately two feet west of a pallet holding 25 lb. boxes of dried apricots.
o On the floor in between the dried apricot pallets mentioned above.
o On the floor in between storage racks surrounding equipment not in use.
o On the floor adjacent to the east wall surrounding what appeared to be beans and approximately 1 foot away from a pallet holding boxes of bubble gum.
o On a lid of a drum, labeled onion salt.
o On the floor adjacent to the north wall next to equipment not in use.
o Directly under, and on the east and south sides of a 15 lb. box of Rosemary. (SAMPLE COLLECTION SITE #1).
o On a wooden pallet of non-food items, and located adjacent to the pallet of Rosemary, mentioned above, which also held a box of onion powder. (SAMPLE COLLECTION SITE #2).
o On the floor adjacent to the east wall and approximately 3 inches away from a pallet holding various types of candy, such as lemon drops and milk chocolate buttons. (SAMPLE COLLECTION SITE #3).
Note: Rodent-like pellets were collected from each of the collection sites identified above and were confirmed by laboratory analysis to be a rat/mouse excreta pellets. In addition, our analyst found rat/mouse hairs in the collected pellets as well.
• One cockroach-like insect on the floor, and two on the interior door frame of the walk-in cooler where shelled walnuts were stored.
• One live flying moth-type insect in the Spice Packaging Room.
• One live crawling cockroach-type insect in the Spice Packaging Room.
• Two dead rodents in a glue trap located on the north side of Unit E.
• Two live crawling cockroach-type insects on the interior door frame of the walk-in cooler.
• Two live crawling cockroach-type insects near the white sink on the west wall of Unit C where finished product is stored.
We acknowledge that on September 28, 2010, in response to our inspection, your firm voluntarily destroyed one pallet containing approximately 80 of the 25 lb. boxes of dried apricots (or approximately 2,000 lbs. of dried apricots), referenced above, which were stored on pallets in areas where the rodent-like excreta pellets were discovered.
We also acknowledge your written response, dated October 11, 2010, which explains that your firm has renegotiated terms of pest control service with your existing pest control company to increase the frequency of visits to address the immediate rodent and vermin infestation at your facility. However, we have concerns that your corrective actions, to date, may not be adequate to resolve the underlying pest problem throughout your facility, in the walls, under pallets of remaining food products, in mechanical areas, within refrigeration units, in areas above suspended ceiling systems, and in similar locations. Please provide detailed information of the terms of your pest control service, and the steps you have taken to monitor screening or other protection against the entry of pests on an ongoing basis. We will evaluate the effectiveness of your corrective actions during the next inspection of your facility.
2) You failed to store and dispose of rubbish and any offal in a manner that would minimize the potential for the waste to become an attractant and harborage or breeding place for pests, as required by 21 CFR 110.37(f). For example, our inspector observed:
• The trash dumpster, located on the immediate south exterior of Unit E, was unable to close properly because it was overflowing with food and other types of waste. On the floor adjacent to the trash dumpster were other boxes of food waste including boxes of chocolates that were melting.
We acknowledge that your written response, dated October 11, 2010, mentions that the area described above was cleaned to remove the debris. In addition, your response further indicates that you are making arrangements with your waste control company to more effectively deal with overflow and other rubbish disposal issues. We note that a similar observation was made in the previous FDA inspection, and seems to be an ongoing violation that your firm has allowed to recur. We will verify your promised correction during our next inspection of your facility.
3) You failed to take reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. Accordingly, employees must wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). For example, our inspector observed:
• On September 27, 2010, a female employee, in the (b)(4) room, re-packed ready-to-eat dried pears with her bare hands, then picked up a box of the dried pears from a pallet, while simultaneously picking up a blue plastic tote and returned to re-packing pears with her bare hands -- without washing or sanitizing her hands.
The above items are not intended to be an all-inclusive list of the objectionable conditions and/or practices in your facility. It is your responsibility to ensure that your establishment and your food products comply with the Act and its implementing regulations. You should take prompt action to correct all violations of the CGMP regulation noted above. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to seizure and/or injunction.
In addition, we have the following comment. We acknowledge that you removed the worn conveyor belt used to transport licorice during the inspection, and that you stated in your written response dated October 11, 2010 that it was being serviced. Please verify that the conveyor belt has been serviced and that your correction has been completed.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent recurrence, including detailed information of the terms of your pest control service, steps you have taken to monitor screening or other protection against the entry of pests on an ongoing basis, and any employee training. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact: Robert McNab, Compliance
Officer at 949-608-4409.
Sincerely yours,
/S/
Alonza E. Cruse
District Director
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