Inspections, Compliance, Enforcement, and Criminal Investigations

Anna's Pies, LLC 3/9/18

 

  

Black HHS-Blue FDA Logo

 

 

Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772 
 
 

 

March 9, 2018
 
Warning Letter 547350
 
VIA UPS
 
Carl W. Manuel, Owner
Anna’s Pies, LLC
2323 Moeling Street
Lake Charles, LA 70601
 
Dear Mr. Manuel:
 
The Food and Drug Administration (FDA) conducted an inspection of your bakery located at 2323 Moeling Street, Lake Charles, Louisiana, from January 9 – 11, 2018. During the inspection, the FDA investigator observed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).
 
At the conclusion of the inspection FDA issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection. Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110 renders your firm’s food products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 United States Code Section 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 can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
 
Your significant violations under section 402(a)(4) of the Act are:
 
1.    Your firm failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigator observed:
  • Approximately 80 apparent rodent excreta pellets (AREPs) located on top of a (b)(4).
  • Approximately 60 AREPs in an open section of an unused (b)(4) stored in between two (b)(4).
  • Approximately 120 AREPs, located on shelves containing miscellaneous dry and canned goods, underneath the (b)(4) table.
  • Approximately 50 AREPs located behind the (b)(4) table.
  • Approximately 40 AREPs, located on shelves containing miscellaneous dry and canned goods, underneath the (b)(4) table in the processing area.
  • Approximately 6 live apparent fruit flies in the processing area during pie crust preparation.
  • 1 dead apparent brown cockroach located inside a round bake pan, next to a pan filled with flour on the (b)(4) table.
  • 1 dead apparent brown cockroach on the floor in the processing area near the roll down door.
  • 1 dead apparent brown cockroach on the floor of the processing area in a corner near the pie wrapping machine.
  • 1 dead apparent brown cockroach on the floor of the processing area near the firm’s pie and cake preparation tables.
  • 2 dead apparent brown cockroaches on a glue trap underneath the (b)(4).
  • Approximately 9 dead apparent brown cockroaches on glue traps behind the (b)(4) in the processing area.
  • Approximately 30 apparent cockroach excreta pellets underneath the bathroom sink, directly adjacent to the processing area.
  • Approximately 50 apparent cockroach excreta pellets on the floor near the west side of the (b)(4) table.
2.    Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, our investigator observed:
  • A hole, with an approximate 2” diameter, leading outside on the north wall of the processing area behind the (b)(4).
  • An approximate 3” wide gap created from an uneven seal of the closed double screen door leading outside on the north wall of the processing area.
  • An approximate 2” wide gap along the bottom of the screen door leading outside on the east wall of the processing area.
3.     Your firm failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required by 21 CFR 110.20(a)(1). Specifically, our investigator observed:
  • A set of pallets, tires, and miscellaneous items piled up near a fence, approximately 10’ from the north side door.
  • Approximately 3 empty beverage containers, 3 empty cleaning agent containers, miscellaneous items, and trash on the north exterior patio, approximately 3’ from the north side door.
  • Approximately 8 empty beverage containers and trash in an approximately 2’ wide hole in the ground near the northwest corner, approximately 4’ from the north side door.
4.    Your firm failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surfaces, as required by 21 CFR 110.20(b)(6). Specifically, our investigator observed:
  • An accumulation of dust and debris on the fan guard of an approximately 30” wide (b)(4), which was in operation and being used to cool, exposed, ready-to-eat (RTE) pecan pies, strawberry cakes, lemon creme cakes, and sweet potato cakes. The fan was located less than 1” away from the RTE pecan pies, strawberry cakes, lemon creme cakes, and sweet potato cakes staged in racks for cooling.
5.   The design, materials and workmanship of your utensils does not allow proper cleaning and maintenance as required by 21 CFR 110.40(a). Specifically, our investigator observed:
  • A fiber from a basting mop was observed mixed into the grease on a bake pan used for baking cakes.
6.    Your plant is not constructed in such a manner as to allow floors to be adequately cleaned and kept clean and kept in good repair as required by 21 CFR 110.20(b)(4). Specifically, our investigator observed:
  • Multiple crevices and exposed aggregate in various areas of the processing floor. The floor contained food debris in multiple locations and standing water in some crevices throughout the processing area.
7.    Your employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated as required by 21 CFR 110.10(b)(3). Specifically, our investigator observed the following insanitary handwashing/sanitizing practices:
  • An employee was observed wiping his forehead with his apron and later using his apron to dry his hands after washing them. The employee returned to placing icing on RTE cakes by hand without washing or sanitizing his hands in between contacts.
  • An employee was observed handling an electrical wire coated with debris and residue. This employee returned to handling dough used for Pig in a Blankets without washing or sanitizing her hands in between contacts.
  • An employee was observed answering the phone and returning to handling cake mix without washing or sanitizing his hands in between contacts. 
8.    You failed to provide safety-type light bulbs and lighting fixtures suspended over exposed food as required by 21 CFR 110.20(b)(5). Specifically, our investigator observed:
  •  An unprotected ceiling fan light, with 4 glass shades, suspended over an open box of pecans during pecan pie production.
9.    Your employees failed to wear beard covers where appropriate as required by 21 CFR 110.10(b)(6). Specifically, our investigator observed:
  • Two employees working in the processing area were observed with facial hair and not wearing beard covers while handling cake mix, preparing sweet potato pies, and icing RTE cakes. 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action such as seizure or injunction, without further notice.
 
Section 743 of the Act (21 U.S.C. 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 noncompliance 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 U.S.C. 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.
 
Please respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the procedures you have taken or will take to completely correct the current violations and prevent similar ones. Please include an update and documentation of your corrective actions as noted above. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the timeframe in which you will complete the corrections.
 
Send your reply to Stephen J. Rabe, Compliance Officer at the address listed in the letterhead or via email to Stephen.rabe@fda.hhs.gov. If you have questions regarding any issue in this letter, please contact Mr. Rabe at 513-679-2700 extension 2163 or Stephen.rabe@fda.hhs.gov.
  
 
Sincerely,
/S/ 
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations - East
 

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