Inspections, Compliance, Enforcement, and Criminal Investigations
Tampa Peanut Distributors 10/8/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|555 Winderley Pl., Ste. 200|
Maitland, FL 32751
RETURN RECEIPT REQUESTED
October 8, 2009
Robert D. Simmons
Tampa Peanut Distributors
4419 North Hubert Avenue, Suite Q
Tampa, Florida 33614
Dear Mr. Simmons:
The United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 4419 North Hubert Avenue, Suite Q, Tampa, FL 33614, on June 2-5, 2009. During the inspection, our investigators observed numerous significant deviations to the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). As such, the conditions in your facility cause the frozen, ready-to-eat (RTE) boiled peanuts manufactured by your firm to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth. You can find the Act and the referenced regulations through links in FDA's homepage at www.fda.gov.
We have received your June 15, 2009, written response to the FDA Form 483, Inspectional Observations, that was issued to your firm on June 5, 2009. Our comments regarding the investigator's observations and the adequacy of the actions you took and/or the verbal commitments you made to our investigator to correct the objectionable conditions and practices observed during the inspection are detailed as follows:
1. To comply with 21 CFR 110.35(c), no pests shall be allowed in any area of your food facility. Furthermore, effective measures shall be taken to protect against the contamination of food on the premises by pests. Visual indications of your lack of effective pest control were observed during the inspection, as evidenced by the following:
• Rodent-gnawed holes in no less than six (6) out of seventeen (17) bags of raw, in-shell peanuts identified as Lot #1030 and three (3) out of thirty-four (34) bags of raw, in-shell peanuts identified as Lot #1024, as well as numerous rodent-gnawed peanuts within and around the referenced bags of raw, in-shell peanuts in your raw peanut storage area;
• No less than twelve (12) rodent excreta pellets (REP's) and five (5) rodent-gnawed peanuts on the floor between the pallet of raw, in-shell peanuts identified as Lot #1030 and the wall of your raw peanut storage area;
• One (1) dead, decomposing rodent stuck to a glue board pest trap and numerous rodent-gnawed peanut shells on the floor in the gap measuring approximately two feet (2') in width between Cooler #1 (i.e., your cold-holding unit that was not operational during the inspection) and the wall in the same room where your raw peanut storage area is located;
• No less than two hundred (200) REP's and ten (10) rodent-gnawed peanut shells in various locations throughout the second level of your facility, which is directly adjacent and open to the raw peanut storage room;
• A rodent urine stain approximately ten inches (10") in length, a patch of fur measuring approximately one inch by one inch (1" X 1"), what appeared to be trails made by rodents traversing through glue board pest traps, and three (3) insect egg casings on the floor of the second level of your facility;
•No less than twelve (12) REP's at the base of the bay door between the exterior of your facility and your raw peanut storage area;
•No less than fifteen (15) REP's in the chemical/equipment storage closet; and
•No less than five (5) dead insects and three (3) dead lizards stuck to glue board pest traps located next to an open bay door which leads directly into the frozen, RTE boiled peanut production room.
2. To comply with 21 CFR 110.20(b)(7), you must provide adequate screening or other protection against pests entering your facility. However, you failed to meet this requirement as evidenced by our investigators' observations, which included, but were not limited to, the following:
• The bay door in your frozen, RTE boiled peanut production room was left open approximately six inches (6") with no screening in place during manufacturing operations.
• There were a number of missing ceiling tiles in the ground level rooms of your facility and several gaps measuring approximately one-half inch (1/2") in width around the edge of the exterior bay door of your raw peanut storage area whereby pests could gain access to your production and storage areas.
3. To comply with 21 CFR 110.355(a), buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition sufficient to prevent food from becoming adulterated. However, the ceiling tiles directly above your uncovered cooking kettles were coated with organic materials from previous RTE boiled peanut cooking operations. In addition, 21 CFR 110.40(b) requires that all seams on food-contact surfaces be smoothly bonded or maintained so as to 2 minimize the accumulation of food particles and other organic materials. However, you failed to meet these requirements as evidenced by the organic residues that we observed to be encrusted on the inner surfaces of your RTE boiled peanut cooking kettles from previous cooking operations (particularly along the roughly welded seams of the kettles) following cleaning and sanitizing operations on June 4, 2009.
4. To comply with 21 CFR 110.80(b)(7), all containers, utensils, and equipment used to convey foods must be maintained in such a way as to protect against contamination. However, you failed to meet this requirement in that the plastic tubs used to transport RTE boiled peanuts from the cooking kettles to the hopper had holes worn in their bottoms and were deeply scratched and stained from previous manufacturing operations. Moreover, these same tubs were being stored on the unclean, unsanitized floor of your facility.
5. To comply with 21 CFR 110.80(b)(2), you must conduct all food manufacturing operations, including packaging and storage, under such conditions and controls as are necessary to minimize the contamination of food. However, you failed to meet this requirement in that you were storing open bags of salt and red pepper (i.e., finished product ingredients) on the same pallet as an open box of plastic bags (i.e., finished product containers) that were heavily soiled with particles of unknown origin.
6. To comply with 21 CFR 110.37(e), you must provide adequate and convenient hand washing facilities. However, you failed to meet this requirement in that we observed no soap, paper towels, sanitizing solutions, or any other means for adequate employee handwashing, drying, or sanitizing at the small handwashing station in your RTE boiled peanut production room.
7. To comply with 21 CFR 110.20(b)(5), you must provide adequate lighting in all areas where food is examined, processed, or stored and where equipment and utensils are cleaned. However, you failed to meet this requirement in that at least one (1) light in your production room was inoperable, the skylights in your facility were opaque with filth,and the light in the back freezer was out. In effect, your facility was so dimly lit that you were unable to adequately monitor for the presence of pests and the accumulation of filth throughout your facility.
We acknowledge and appreciate the immediate corrective actions you took during the inspection to remedy some of the deviations observed by our investigators. The following corrective actions were confirmed by the lead investigator prior to the close of the inspection:
• You voluntarily destroyed 51/50-lb. bags of raw, in-shell peanuts (Lots #1030 and 1024).
• You had your pest control service visit your facility for immediate treatment.
• You removed the evidence of pests from your production and storage areas.
• You removed everything from the second story storage facility (with the exception of a fan) and cleaned out the chemical storage closet.
• You purchased plastic tubs with lids for the open bags of spices and moved all spices into the closet formerly used to store chemicals.
• You purchased plastic sheets to fashion covers for the cooking kettles and the hopper to protect the food contact surfaces of the equipment when the equipment was not in use.
We also acknowledge the verbal commitment you made to the lead investigator to voluntarily cease your frozen, RTE boiled peanut processing operations until the most significant of the remaining observations listed on the FDA Form 483 are corrected. In addition, we acknowledge receiving your written response to the FDA 483 dated June 15, 2009, in which you provided us with the current status of your corrective actions. Based on your statements, it appears that you are taking the appropriate steps to bring your firm into compliance with the food CGMP regulation. FDA will evaluate and verify these corrections during the next inspection.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that your products are in compliance with all applicable laws and regulations. You should act quickly to correct the regulatory deviations noted in this letter. Failure to correct may result in regulatory action without further notice, such as seizure of your products and/or injunction of your firm.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should include any documented evidence of corrective actions already accomplished. Proof of your corrections may include, but is by no means limited to, copies of reports from your pest service contractor and photographs showing the repairs and renovations referenced in your responses. If you cannot complete all corrections before you respond, please explain the reason for your delay and provide us with a timeframe for the correction of any outstanding violations.
Please send your response to the Food and Drug Administration, Attention: Matthew B.Thomaston, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, please contact Mr. Thomaston at (407) 475-4728.
Emma R. Singleton
Director, Florida District