Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
April 4, 2014
Dominic Serpe, President
Serpe & Sons, Inc.
1411 Kirkwood Highway
Wilmington, DE 19805-2123
Dear Mr. Serpe:
The U.S. Food and Drug Administration (FDA) inspected your food processing facility, located at 1411 Kirkwood Highway, Wilmington, DE, on February 27, 2014 through March 6, 2014. We found that you have serious violations of the Current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations, (21 CFR), Part 110. These violations cause the food products manufactured/distributed at your facility 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page at www.fda.gov.
Specifically, our inspection of your facility revealed the following violations:
1. Your firm failed to maintain equipment, containers, and utensils used to convey and hold food, in a manner that protects against contamination during manufacturing and/or storage [21 CFR 110.80(b)(7)]. Specifically, on February 27, 2014, our investigator observed cobwebs and dust directly above a scale filled with shortening. This shortening was being used to make bread dough and the dough is used to manufacture sandwich rolls. In addition, there were cobwebs directly above machinery being used to form Kaiser Rolls, and an open container of flour used in the production of the Kaiser Rolls was observed on top of the Kaiser Roll machine.
2. Your firm failed to store raw material in a manner that protects against contamination [21 CFR 110.80(a)(1)]. Specifically, on February 27, 2014 our investigator observed open bags of flour, used in the production of sandwich rolls, cakes and pastries, stored directly under a refrigeration unit that had visible filth, dust, and cobwebs on it. Further, open bags of sugar, flour, and other dry ingredients were stored on top of a wooden pallet, in close proximity to pooling water on the floor. On March 4, 2014, open bags of sugar, flour, and other dry ingredients, were observed being stored with a plastic covering over them and that covering had visible filth and old masking tape on it.
3. Your firm failed to provide sufficient space for placement of equipment as necessary for the maintenance of sanitary operations and the production of safe food [21 CFR 110.20(b)(1)]. Specifically, on February 27, 2014, our investigator observed racks used in the production of bread, cakes, and pastries being held outside of the production area dock door, as a result of there being no room in the production area to store them. These racks were then observed being moved from outside, into the production area, to place trays of bread dough on them without being cleaned. On March 4, 2014, these racks were observed outside the production area dock door. A flock of birds flew over the racks, and then rested on the top of them.
4. Your firm failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food-contact surfaces [21 CFR 110.35(a)]. Specifically, on February 27, 2014, our investigator observed visible stains, build-up of cobwebs, and a broken fan on top of the bread proofer, while dough for sandwich rolls was in production. This build-up of cobwebs and the broken fan were in close proximity to the exposed dough in the cups of the proofer.
5. Your firm failed to store and transport finished food under conditions that would protect against physical contamination [21 CFR 110.93]. Specifically, on February 27, 2014, our investigator observed your staff packing sandwich rolls in preparation for delivery into large cardboard trays that were stacked directly on the concrete floor of the production area. A staff member was observed leaning the bottom of the cardboard tray on to the cooling racks, which housed the sandwich rolls; thus, bringing the bottom of the tray in contact with the finished product. Once the tray was filled, each tray was then stacked on the previously filled tray; again bringing each tray bottom in direct contact with the finished product.
6. Your firm failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition [21 CFR 110.35(a)]. Specifically, on February 27, 2014, our investigator observed bread dough on racks being held in the refrigerator directly beneath the cooling unit fans, which had a visible accumulation of dust and filth on them.
7. Your firm failed to provide employees suitable outer garments to be worn, that protect against contamination of food and food contact surfaces [21 CFR 110.10(b)(1)]. Specifically, on February 27, 2014, our investigator observed a staff member wearing a visibly dirty sweatshirt, leaning over into a bin of bread dough while moving the dough from the transfer bin into the funnel of the bread proofer.
8. Your firm failed to properly identify and store toxic cleaning compounds in a manner that protects against contamination of food [21 CFR 110.35(b)(2)]. Specifically, on February 27, 2014, our investigator observed an unlabeled spray bottle filled with a red liquid lying on top of a rack just above flour being held for the production of sandwich rolls, cakes and pastries.
9. Your firm failed have plumbing that is properly installed and maintained to provide adequate floor drainage [21 CFR 110.37(b)(4)]. Specifically, on February 27, 2014, our investigator observed pooling water in the corner of the bread production area where dry ingredients were being held, on top of a wooden pallet. There were no visible drains noted in this area.
10. Your firm failed to adequately store personal belongings so that they were not in an area where food is exposed and equipment or utensils are washed [21 CFR 110.10(b)(7)]. Specifically, on February 27, 2014, our investigator observed two pairs of boots stored on top of the racks in which raw materials were stored, in the pastry production area. In addition a pair of boots was stored on top of racks used to store clean cooking trays, in the dish washing area.
11. Your firm failed to have effective hand cleaning preparations [21 CFR 110.37(e)(2)]. Specifically, on February 27, 2014, our investigator observed that there was no soap in the hand soap dispenser and there was no trash receptacle, at the only hand washing station in the bread production area.
12. Your firm failed to have posted, readily understandable signs directing employees to wash and sanitize hands as appropriate [21 CFR 110.37(e)(5)]. Specifically, our investigator observed that there was no posted sign directing employees to wash or sanitize hands, near the only hand washing station in the bread production area.
13. Your firm failed to construct your plant in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and in good repair [21 CFR 110.20(b)(4)]. Specifically, on February 27, 2014, our investigator observed portions of the floor in the production area that are constructed of unsealed concrete, while other portions were tiled. The unsealed concrete areas cannot be adequately cleaned.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You should take prompt action to correct the violations described above and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, including but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
Further, 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 notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. .
Your written response should be sent to Lynn S. Bonner, Compliance Officer at the address on this letterhead. If you have any questions about this letter, please contact Ms. Bonner at 215-717-3074 or email her at Lynn.Bonner@fda.hhs.gov.
Anne E. Johnson
Acting District Director