|Subject:||CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions|
|Issuer:||Denver District Office|
|Issued:||March 23, 2010||Closed:||Jan. 19, 2011|
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
March 23, 2010
VIA FED EX
Beryl Stafford, Owner
4725 Nautilus Court South
Boulder, CO 80301
Ref. #: DEN-10-09 WL
Dear Ms. Stafford:
This letter is in reference to the inspection of your firm, Simplydelicious LLC dba Bobo's Oat Cakes, located in Boulder, Colorado, conducted by an investigator from the Food and Drug Administration (FDA) November 30 through December 9, 2009. The inspection was conducted to determine compliance with FDA's Current Good Manufacturing Practice (CGMP) requirements for manufacturing, packing, or holding human food, Title 21
Code of Federal Regulations
(CFR), Part 110 (21 CFR 110). Our investigator documented serious deviations from the applicable regulations that cause your ingredients and finished food products 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)]. You can find the Act and the regulations through links in FDA's homepage at www.fda.gov.
Your significant violations are as follows:
1. Failure 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). During the December inspection the investigator observed the following:
• A live rodent was observed in the production area of the bake room beneath a storage rack containing raw materials and utensils.
• Approximately twenty-one rodent excreta pellets were observed in the production bake room on a wooden pallet directly below a torn 50 lb. bag of oats, amongst the spillage
• Urine stains and seven rodent excreta pellets were observed between two 50 lb. bags of sucanat stored in the warehouse area.
• A two inch by five inch by six inch deep hole was observed along the floor and wall juncture near the northwest comer of the warehouse. Nesting material and two rodent excreta pellets were observed in this hole.
In addition, numerous rodent excreta pellets were observed in several other locations in your warehouse and gaps were observed under doors with access to production and warehouse areas. Pest infestation conditions were noted in your previous location and pest control has been an issue in your past four inspections conducted by FDA personnel and Colorado Department of Public Health and Environment (CDPHE) for the Agency.
2. Failure to properly store equipment and remove litter and waste from the grounds about the plant as required by 21 CFR 110.20(a)(1). Accumulated unused equipment was observed outside of your building, along both sides of the receiving dock door.
3. Failure to use equipment and/or utensils of an appropriate design to preclude the adulteration of food with metal fragments and contaminants as required by 21 CFR 110.40(a). Specifically:
• An employee was observed using a construction-type cordless drill with a painted metal mixing paddle for mixing liquid oat bar ingredients. The paint was observed to be chipped in several places on the mixing paddle and the mixing paddle was not constructed of food grade material.
• An employee was observed using a hand-made plastic spatula-type utensil with two exposed screw heads to flatten in-process oat bar dough into pans. The screw heads came in direct contact with product and were not removable for cleaning. Plastic molding on this utensil was cracked and the edges were split.
4. Failure to maintain all equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing as required by 21 CFR 110.80(b)(1). Specifically, soap was not observed to be used in the process of cleaning pots/pans, utensils, or other equipment utilized in the production of allergen (peanut butter) and non-allergen containing product.
5. Failure to maintain gloves used in food handling in an intact, clean, and sanitary condition as required by 21 CFR 110.10(b)(5). On November 30, 2009, a gloved employee was observed to leave the packaging line, touch the refrigerator door handle, move a rack of oat bars within the refrigerator and then return to the packaging line where he touched finished ready-to-eat unpackaged oat bars without changing, washing, or sanitizing his gloved hands.
6. Failure to provide hand-washing facilities that are adequate and convenient as required by 21 CFR 110.37(e). Specifically observed was no sanitary towel service or suitable hand drying devices as required by 21 CFR 110.37(e)(3). Although your firm had cloth towels for hand drying in a cabinet next to the baking room hand sink, employees would have had to open the cabinet to access the towels; moreover, there was no laundry receptacle present in the hand sink area for the collection of cloth towels. It was not observed that your employees were accessing the cloth towels in the cabinet.
We acknowledge the voluntary disposal and cleaning during the inspection of spilled raw materials that appeared to be contributing to conditions in your facility whereby your product may become adulterated. We acknowledge corrections were promised during discussions with you and your management at the conclusion of the inspection. We also note that your firm has not provided a corrective action plan addressing the violations identified in the December 2009 inspection or a plan to ensure long-term compliance with the Good Manufacturing Practice regulations for foods under 21 CFR 110.
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 ensuring that your food facility operates in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action may result in regulatory action being initiated without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the noted violations. In your response, include documentation such as certification of actions performed to control the unauthorized entry of pests, plans on how you propose to protect food products from possible contamination, and/or any other useful information that would assist us in evaluating your corrections. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Address your reply to the U.S. Food and Drug Administration; Attn: Nancy G. Schmidt, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087: You may reach Ms. Schmidt at (303) 236-3046 with any questions you may have regarding this matter.
H. Thomas Warwick, Jr.
Denver District Director