| Public Health Service Food and Drug Administration |
| Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863 |
Department of Health and Human Services
June 1, 2011
WARNING LETTER
CHI-13-11
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Lloyd H. Culbertson
President
Rolfs Patisserie
4343 West Touhy Avenue
Lincolnwood, Illinois 60712
Dear Mr. Culbertson:
From December 23, 2010 through February 23, 2011, the U.S. Food and Drug Administration (FDA) inspected your food manufacturing facility located at 4343 West Touhy Avenue, in Lincolnwood, Illinois. During the investigation we collected samples consisting of environmental swabs. Analysis of the environmental swabs, sample numbers 626394, 626963 and 660382, indicates the presence of Staphylococcus aureus (S aureus) in your facility and raw material topping used in finished baked good product. In addition, we found significant violations of FDA's Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110) at your facility. These violations and the results of the laboratory analysis of the environmental swabs cause the food products manufactured in 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 may find the Act and FDA's regulations through links in FDA's website at www.fda.gov.
Our inspection of your facility revealed the following violations of the CGMP regulations (21 CFR Part 110):
1) Failure to conduct cleaning and sanitizing of equipment in a manner that protects against contamination of food and food-contact surfaces to comply with 21 CFR 110.35(a). Environmental samples 626963, 660382, and 665259 collected from your processing room equipment (including food-contact surfaces) and sample 660394, collected from your raw material topping, confirmed the presence of multiple enterotoxigenic (toxin-producing) strains of S. aureus. The diversity and widespread nature of contamination in your facility, including repeat findings from food contact surfaces even after those surfaces were cleaned and sanitized on December 27, 2010 and January 10, 2011, indicates that your cleaning and sanitation operations were ineffective, and that your firm has been operating under insanitary conditions which may reasonably cause contamination of food with this organism, and which may lead to toxin formation.
We acknowledge your letter of April 12, 2011 and your corrective actions including increased frequency of cleaning and sanitation of utensils, food equipment and food contact surfaces, and instructing employees on the proper me of detergents and sanitizers. However, we consider your response to be inadequate in that it does not address our concern about the effectiveness of your cleaning and sanitizing operation. We recommend that you re-evaluate the effectiveness of your cleaning and sanitation operation, and submit documentation of your corrections (e.g. revised Sanitation Standard Operating Procedures, documentation of appropriate use and strength of sanitizers, completed daily monitoring records for cleaning and sanitizing, employee training information, etc.) and other steps you are taking to ensure control of microbial contamination on a continual basis. While we acknowledge your verbal commitment (made at the close of the inspection) to increase the strength of your sanitizers, you should provide documentation of this correction. Effective cleaning and sanitizing operations and sanitary employee practices are critical to control microbial organisms in your food processing facility, and to prevent contamination of food from the environment.
2) Failure to hold foods that can support the rapid growth of undesirable microorganisms in a manner that prevents the food from becoming adulterated within the meaning of the Act, to comply with 21 CFR 110.80(b)(3). Specifically, on January 11, 2011, a five gallon pail of what appeared to be dairy-containing pastry cream dated 1/10/11 was left out on the production table at room temperature for at least two hours during manufacturing. The cream was being used in the production of atom cakes.
Exposure to temperatures favorable for S. aureus growth for sufficient time can allow for enterotoxin production. Accordingly, processing/storage temperature and time exposures are critical for reducing the risk of foodborne illness due to S. aureus enterotoxin. Foods, such as cream-filled pastries, that require considerable handling during preparation and that are kept at slightly elevated temperatures after preparation (over 45°F but below 140°F) are frequently involved in staphylococcal food poisoning.
We acknowledge your letter of April 12, 2011, which states that you have taken the corrective action of requiring that employees notify supervisors at the completion of each assembly task and verify that all finished in-process and ingredients have been properly stored and refrigerated. We will verify implementation of this correction at the next inspection.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that your facility and all of your products are in compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations listed above and take prompt actions to correct the violations and to bring your products into compliance. Failure to promptly correct these violations and implement lasting corrective action may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken or plan to take. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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 written response should be sent to Rosemary Sexton, Compliance Officer, U.S. Food and Drug Administration, 550 West Jackson Boulevard, Suite 15, Chicago, Illinois 60661. If you have any questions about this letter, please contact Compliance Officer Rosemary Sexton at 312-596-4225.
Sincerely,
/S/
Scott J. MacIntire
District Director
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