Inspections, Compliance, Enforcement, and Criminal Investigations

Gemdo Cosmetics, Inc. 4/16/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
 
Telephone: 949-608-2900      
FAX: 949-608-4415

 

WARNING LETTER
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
April 16, 2015
WL # 16-15
Patricia Alvarez, President
Gemdo Cosmetics Inc.
29151 Ave. Penn
Valencia, CA 91355-5441
 
Dear Mrs. Alvarez:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your contract cosmetic manufacturing facility located at 29151 Ave. Penn, Valencia, California, on December 8, 2014 through December 23, 2014 in response to a Class II Recall of Juice Beauty Illuminating Eye Shadow products (chocolate, cappuccino, and champagne shades), manufactured at your facility, that were found to be contaminated with the ocular pathogen, Bacillus cereus. In addition, during our inspection we also inspected your firm’s compliance with the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321 et seq.]. Your firm is a contract manufacturer for various products, including Juice Beauty, Inc. The products you manufacture, pack and label are intended to be applied to the human body for beautifying, promoting attractiveness, or altering the appearance, and as such, they are cosmetics within the meaning of section 201(i) of the Act [21 U.S.C. 321(i)]. The microbial contamination of the Juice Beauty Illuminating Eye Shadow 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. Furthermore, the conditions observed during the inspection cause Juice Beauty Illuminating Eye Shadow products and other eye area products manufactured in the dry room to be adulterated within the meaning of section 601(c) of the Act [21 U.S.C. 361(c)], 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. The Juice Beauty Illuminating Eye Shadow (chocolate, cappuccino, and champagne shades) products manufactured at your facility are adulterated under section 601(a) of the Act in that they were found by FDA laboratory analysis to contain the ocular pathogen, Bacillus cereus which may render the products injurious to health. Bacillus species are Gram-positive rod-shaped bacteria that are widely found in the environment, such as soil, dust, water, and sediments. Their spores are resistant to desiccation and heat, and therefore are able to survive the manufacturing process. Vegetative cells produce a range of toxic enzymes responsible for tissue destruction and reactivity.
 
Particularly, Bacillus cereus contaminated eye-area products may cause users to develop bacterial conjunctivitis, keratitis and periorbital cellulitis. In particular, this pathogen can cause a rapidly progressive endophthalmitis (i.e., inflammation of the intraocular cavities or the aqueous and/or vitreous humor of the eye) that is resistant to treatment. Significant loss of vision, and often loss of the eye itself, can occur within 24 to 48 hours after exposure to B cereus.   
 
Additionally, Juice Beauty Inc. Illuminating Eye Shadow products are formulated with preservative systems other than the preservative systems listed under Appendix C of FDA Compliance Program Guidance 7329.001 (available at http://www.fda.gov/downloads/Cosmetics/GuidanceRegulation/GuidanceDocuments/UCM208412.pdf). Cosmetics need not be aseptic, however, they must not be contaminated with microorganisms which may be pathogenic, and the density of non-pathogenic microorganisms should be low (see FDA’s Bacteriological Analytical Manual (BAM), “Chapter 23: Microbiological Methods for Cosmetics,” Section C-Interpretation available at http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm073598.htm). It appears that adequate testing was not performed, as your firm could not provide the documents for FDA review. FDA notes that quality control testing of incoming materials is a fundamental part of cosmetic good manufacturing practices and solely relying on certificates of analysis from a vendor is not advised by the Agency. Dry powders and raw materials of natural origin used in shaded and eye area cosmetics are likely to carry high numbers of B. cereus spore forming organisms. Botanical, organic and inorganic raw ingredients are especially vulnerable to microbial contamination and should be afforded increased scrutiny by cosmetic manufacturers prior to their use.
 
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 December 8, 2014 through December 23, 2014 inspection that cause the Juice Beauty Illuminating Eye Shadow products and the other products manufactured in the production area where the Juice Beauty eye shadow products were manufactured to be adulterated. Specifically, environmental samples taken from the production area on and around (b)(4) and (b)(4) in the dry room were found contaminated with Bacillus cereus. These findings suggest insanitary conditions and that the work environment was supporting the growth of B. cereus. The findings also suggest that manufacturing operation or conditions at this facility may be operated in a manner which is likely to, or may have contributed to the contamination and adulteration of the eye area and other cosmetic products processed in the dry room. The growth and presence of B. cereus in the dry room could be caused by a failure to properly clean and sanitize. This includes a disinfection regime that disinfects, kills or inactivates spores. Bacillus endospores in particular are resistant to hostile physical and chemical conditions; this means that they can be difficult to remove without an effective sanitization regime. FDA noteseffective monitoring and sanitation controls for cosmetic products and control of the processing environment is important to controlling microbiological growth in cosmetic products.
 
In addition, our inspection revealed insanitary practices that may lead to insanitary conditions that may cause your products to become contaminated with filth or rendered injurious to health. Specifically, we observed that:
·    The microbial safety of raw materials is not routinely evaluated in that materials are not sampled and tested or examined in conformance with specifications that could ensure the absence of contamination with filth, microorganisims or other adulterants to the extent necessary to prevent adulteration of finished products. In particular, you stated to our inspector that you do not routinely test incoming lots of raw materials used in the manufacture of cosmetic products prior to their use, in order to confirm suitability. Sufficient controls are necessary to ensure that materials are of suitable cleanliness prior to entry into the cosmetic processing area to prevent product contamination.
·    You do not routinely review raw material records, including records of origin, receipt, examination, testing, disposition, and use, to determine if raw material is adequately controlled. In particular, you do not have written quality control measures for the raw materials used to manufacture cosmetics at your facility and our inspector observed that the following ingredients, which may have been used in the manufacture of cosmetic products in your facility were past their recommended use dates: (b)(4). Although you indicated that the vendor’s certificates of analysis of raw materials demonstrated quality control measures, we recommend that you review raw material records and establish written procedures that help to better control the examination, testing, disposition, and use of raw materials.  
 
Accordingly, the Juice Beauty Eye Shadow products and the other eye area products manufactured in the same production room as Juice Beauty Eye Shadow are adulterated within the meaning of section 601(c) of the Act. We note that, in our Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for cosmetics, we recommend a number of guidelines for effective self-inspection that may assist cosmetic manufacturers to minimize the risk of adulteration. These guidelines are available at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm
 
We also note that contaminated Juice Beauty Illuminating Eye Shadow (chocolate, cappuccino, and champagne shades) products were recalled in August 2014. Because of the contamination in your facility, 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 caused by use of contaminated raw materials and subsequently provide for the safe distribution of these 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.
 
Please notify this office 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 the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented. 
 
If you have any questions about this letter, please contact Compliance Officer at (949) 608-2918 or Raymond.Brullo@fda.hhs.gov.
 
Your response should be sent to:
 
CAPT Daniel Cline, Acting Director
Compliance Branch, Los Angeles District
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc:
David M. Mazzera, Chief, Food and Drug Branch
California Department of Public Health
PO Box 997435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413

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