Gilchrist & Soames 3/16/16
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, Ml 48207
March 16, 2016
Ms. Kathie De Voe
President and Chief Executive Officer
Gilchrist & Soames, Inc.
2425 East Perry Road, Suite 150
Plainfield, IN 46168-7620
Dear Ms. De Voe:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your Gilchrist & Soames, Inc., cosmetic manufacturing facility located at 2425 East Perry Rd., Plainfield, Indiana, from September 22 to October 5, 2015 to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act). Your firm manufactures and distributes hotel amenity products, including shower gels, shampoos, lotions, and conditioners, to retail and charitable organizations. These products are intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, and as such, are cosmetic products within the meaning of section 201(i) of the Act [21 U.S.C. §321(i)].
Our investigators collected a sample of your "Gilchrist & Soames Spa Therapy Conditioning Shampoo" product during the inspection, and "(b)(4)
Shower Gel," "Pelican Hill Shower Gel," and "Essential Elements Shampoo" products post-inspection. Our analysis of these products, manufactured at your facility, found significant microbial contamination. The microbial contamination of the "Gilchrist & Soames Spa Therapy Conditioning Shampoo," "(b)(4)
Shower Gel," "Pelican Hill Shower Gel," and "Essential Elements Shampoo" products causes these products to be adulterated within the meaning of section 601(a) of the Act [21 U.S.C. §361 (a)], as described further below. It is a violation of section 301 (a) of the Act [21 U.S.C. §331(a)] to introduce or deliver for introduction into interstate commerce an adulterated cosmetic. 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 "Gilchrist & Soames Spa Therapy Conditioning Shampoo," "(b)(4) Shower Gel," "Pelican Hill Shower Gel," and "Essential Elements Shampoo" products are adulterated within the meaning of section 601(a) of the Act [21 U.S.C. § 361(a)) for the following reasons:
1. FDA analysis of your "Gilchrist & Soames Spa Therapy Conditioning Shampoo" and "(b)(4) Shower Gel" products determined that of the five subsamples analyzed for each product, all contained the pathogen Pseudomonas aeruginosa. P. aeruginosa is opportunistically pathogenic to humans and highly resistant to antibacterial agents such as quaternary ammonium compounds, penicillin, and many broad-spectrum antibiotics. It is among the most virulent opportunistic pathogens and can cause severe and life-threatening infections (especially in immunocompromised patients, burn patients, patients suffering from respiratory disease, cancer, chemotherapy patients, etc.). P. aeruginosa can survive in topical and eye-area cosmetics and has been implicated in significant eye infections which may lead to corneal ulcers and blindness.
Cosmetic products are not expected to be aseptic; however, they must be free of high-virulence microbial pathogens and the total number of aerobic microorganisms per gram must be low (Bacteriological Analytical Manual (BAM), Chapter 23: Microbiological Methods for Cosmetics, Section C- Interpretation. http://www. fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm073598.htm).
2. FDA analysis of your "Gilchrist & Soames Spa Therapy Conditioning Shampoo," "(b)(4) Shower Gel," "Pelican Hill Shower Gel," and "Essential Elements Shampoo" products determined that the subsamples of the products contained an excessive level of microorganisms as evidenced by high Aerobic Plate Counts (APC), which may render them injurious to users because the presence of such microorganisms in these finished products can increase the users' risk of infection. APC measures the level of microorganisms in a product and can indicate the quality of the product. FDA's guideline is that the APC should not be greater than 500 CFU/g for eye area cosmetics and 1,000 CFU/g for all other products. These guidelines can be found in the BAM (see the above citation). Specifically, your products contained APC of up to 210,000,000 CFU/m. Of particular concern, the high counts of Enterobacter gergoviae. Enterobacter gergoviae are part of the normal intestinal flora and may be considered an opportunistic pathogen. Individuals with weakened immune systems, who suffer from a serious pre-existing condition, who have been treated surgically or belong to another sensitive group of persons are at particular risk of infection.
Our investigators also observed the following insanitary practices that could cause your products to be adulterated under section 601(c) of the Act in that these practices may lead to insanitary conditions and may cause the products manufactured in your facility to become contaminated with filth or rendered injurious to health. Specifically, we observed that:
1. The microbiological safety of starting materials and/or raw ingredients is not routinely evaluated by your firm. Materials are not sampled and tested for conformance with specifications and to ensure the absence of filth, microorganisms, and other adulterants prior to processing or usage. Your firm does not perform any microbial testing on any incoming raw materials, nor have you validated your suppliers' quality testing through independent verification.
We acknowledge receipt of your firm's October 14, 2015, October 27, 2015, December 8, 2015, December 21, 2015, and January 19, 2016, letters sent in response to the FDA 483 issued to your firm at the close of the inspection. In your letters you stated that you are currently evaluating raw material inventory and determining which raw materials are micro-sensitive. We also note that you state that you send micro-sensitive raw materials to be tested for microbiological content at an external laboratory. We cannot evaluate the adequacy of your corrective actions without the supporting documentation.
2. The equipment used to manufacture your products is not maintained in a clean and orderly condition, or sanitized at appropriate times. Your firm was also unable to document clean out procedures for (b)(4) gallon bulk raw material tanks and (b)(4) gallon tank (b)(4) water tank use for manufacturing and equipment cleaning. As suggested in FDA's Draft Guidance for Industry: Cosmetic Good Manufacturing Practice, FDA expects cosmetic firms to document equipment cleaning and procedures and assure that the processes are adequate to prevent adulteration.
In your firm's response letters you provided a date of February 29, 2016, for your cleaning validation studies to be completed. We also note that you state water samples are being collected and analyzed by your third-party lab. We cannot evaluate the adequacy of these corrective actions without the supporting documentation.
3. Raw materials, in-process samples and finished products should be tested or examined to verify their identity and determine their compliance with specifications for physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants. However, your products continue to be contaminated with microorganisms. Specifically, P. aeruginosa was isolated by FDA from a sample of 1.5 oz bottles of "Thymes naia Body Wash" lot 1308, collected by an FDA investigator on December 17, 2014. The analytical results for this sample were sent to you on March 6, 2015. Yet, P. aeruginosa was isolated from FDA samples of "Gilchrist & Soames Spa Therapy Conditioning Shampoo," packaged in June, 2015, and " (b)(4) Shower Gel," "Pelican Hill Shower Gel," and "Essential Elements Shampoo," all packaged in September, 2015.
We acknowledge that you have recalled several products due to microbiological contamination. Specifically, (b)(4) Conditioning Shampoo batch 1320411346 lot 1308, London Shower Gel batch 1322707388 lot 1308, AM Resorts Dreams Conditioning Shampoo batches 1320410798 and 1320410603 lot 1307, Chamomile Mineral Bath batch 1320607414 lot 1308, and Neil George Body Wash batch 1314907424 lot 1307. Because of the extent of the contamination in your products, we recommend that you implement quality controls and/or reconditioning processes to ensure the safety of the products you manufacture. Additionally, we recommend that you develop a remediation plan to correct and prevent future product contamination and subsequently provide for the safe distribution of your products.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products manufactured, processed, and packed by your firm comply with the Act and its implementing regulations. We advise you to develop a plan for preventing the recurrence of these violations or the occurrence of other violations. We request that you take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action, seizure and/or injunction, without further notice.
We request that you reply in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. You should include in your response any documentation or other useful information that would assist us in evaluating your corrections. If corrective action cannot be completed within 15 working days of receiving this letter, we expect that you will state the reason for the delay and the time frame within which the corrections will be completed.
Your written response should be sent to Seri Essary, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Essary at (313) 393-8150.
Art O. Czabaniuk
Detroit District Office