Inspections, Compliance, Enforcement, and Criminal Investigations
Vienna Beauty Products 5/17/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
May 17, 2012
Via United Parcel Service
Mr. Timothy K. Miller, President
Vienna Beauty Products
347 Leo Street
Dayton, Ohio 45404
Dear Mr. Miller:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your cosmetic manufacturing facility located at 347 Leo Street, Dayton, OH on October 17-18, 25, November 7, and December 22, 2011 to determine your firm’s compliance with the Federal Food, Drug, and Cosmetic Act (the Act). Your Triple Lanolin Aloe Vera Foot Scrub is intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, and as such, it is a cosmetic within the meaning of section 201(i) of the Act [21 U.S.C. 321(i)]. During the inspection, our investigators observed and documented insanitary conditions. An analysis of your Triple Lanolin Aloe Vera Foot Scrub collected during the inspection found significant microbial contamination. The microbial contamination of the product, in conjunction with the conditions observed during the inspection, causes your Triple Lanolin Aloe Vera Foot Scrub to be adulterated within the meaning of Sections 601(a) and (c) of the Act [21 U.S.C. 361(a) and (c)]. It is a violation of Section 301(a) of the Act [21 USC 331(a)] to introduce or deliver for introduction into interstate commerce any cosmetic that is adulterated or misbranded. You may find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov.
Under Section 601(a) of the Act [21 U.S.C. 361(a)], a cosmetic is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. Your Triple Lanolin Aloe Vera Foot Scrub is adulterated in that it bears or contains an excessive level of microorganisms as evidenced by high Aerobic Plate Counts (APC), which may render it injurious to health. APC measures the level of microorganisms in a product and can indicate the quality of the product. Cosmetics must be free of high-virulence microbial pathogens and the total number of aerobic microorganisms per gram must be low. FDA has established a guideline for non-eye area products in which the APC should not be greater than 1000 CFU/g. FDA analysis of your Triple Lanolin Aloe Vera Foot Scrub determined that Composite sample 1 contained 150,000 APC/g and Composite sample 2 contained 98,000 APC/g. Of particular concern, the pathogens Pseudomonas aeruginosa and Burkholderia multivorans/B. cepacia group were identified in the product. Many of these bacteria are widespread in the environment and may be introduced into a cosmetic manufacturing facility from raw materials, water and equipment.
Under Section 601(c) of the Act [21 U.S.C. 361(c)], a cosmetic is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Insanitary conditions were observed during our inspection that causes your Triple Lanolin Aloe Vera Foot Scrub product to be adulterated. Specifically, there was apparent filth and dust build up on manufacturing equipment in the production area. A layer of sediment and encrusted material was observed on the exterior and tops of production kettles in use. Information obtained during the inspection indicates that the production room floor is cleaned and sanitized once per year; the last cleaning was performed November 2010 during a shutdown period. Based on other information obtained during the inspection, the 250 and 500 gallon kettles were last cleaned 15 years ago. The last cleaning of the 400 gallon shower gel kettle could not be determined. Additionally, the finished product storage tank and storage totes were said to have last been cleaned over 20 years ago.
During the inspection several insanitary practices were observed that have the potential to cause your product to be contaminated with filth or become injurious to health. For Example:
1. The microbial safety of starting materials does not appear to be routinely evaluated. Materials are not sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent adulteration of finished products.
2. Fixtures, ducts and pipes are not installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or finished products in bulk. The FDA investigator was advised that during summer month’s condensation may form on piping above manufacturing kettles which may subsequently drip into kettles. This condition may result in microbial contamination of the product.
3. Failure to regularly test water used as a cosmetic ingredient to assure chemical and microbiological quality. Routine testing of the water supply used in the facility to formulate cosmetics and clean equipment and manufacturing areas should be conducted to assure that it is not a source of contamination.
4. Production area and the equipment for processing, transfer and filling equipment and the containers for holding raw and bulk materials are not well maintained, cleaned and sanitized at appropriate intervals.
5. Raw materials and primary packaging materials are not stored and handled in a manner which prevents their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture. Specifically, the investigator observed one 50 lb bag of Cetyl Alcohol, Lot 1698110315FAL-T23 stored directly on the production floor. Cetyl Alcohol is used in all of the firm’s lotion products.
6. Manufacturing controls have not been established, and written instructions, i.e., formulations, processing, transfer and filling instructions, in-process control methods etc., are not being maintained.
7. Samples of cosmetic products are not taken, as appropriate, during and/or after processing, transfer or filling to determine adherence to internal quality standards and absence of hazardous microorganisms or chemical contaminants. The FDA investigator was advised that in 2007 your firm ceased microbial testing of all labeled products. Your plant manager provided documentation that from 2000 to present at least 22 occasions of microbial contamination of the finished product occurred. Your firm did not identify the cause of the microbial contamination.
8. There is a failure to maintain complete control records of raw materials, primary packaging materials, batch and quality control records. Batch and quality control records should include (1) kinds, lots and quantities of material used; (2) processing, handling, transferring, holding and filling records; (3) sampling, controlling, adjusting and reworking recodes and (4) code marks of batches and finished products.
We acknowledge the receipt of your response dated November 9, 2011. However, we find your response to be inadequate in that you did not provide any detailed information regarding proposed corrective actions that the firm plans to take.
This letter may not list all the violations at your facility. You are responsible for investigating and determining the causes of the violation identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility as a manufacturer to ensure that the products your firm markets are safe and otherwise in compliance with all applicable legal and regulatory requirements.
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in enforcement action without further notice, including but not limited to, seizure and/or injunction. You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed.
Your written response should be sent to Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Hunter at 513-679-2700 Ext. 2134.
Paul J. Teitell
Cincinnati District Office