FDA Sends Warning Letter to Gemdo Cosmetics

The U.S. Food and Drug Administration (FDA) has sent a warning letter to Gemdo Cosmetics of Valencia, CA  following an inspection of the contract cosmetic manufacturing facility on December 8, 2014 through December 23, 2014. The nspection was conducted in response to a Class II Recall of Juice Beauty Illuminating Eye Shadow products (chocolate, cappuccino, and champagne shades), manufactured there, that were found to be contaminated with the ocular pathogen, Bacillus cereus.
 
In its letter, which was dated April 16, FDA said that during the inspection the agency also inspected your firm’s compliance with the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321 et seq.]. 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.

The full letter can be accessed here.
 
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
 
Accoding to FDA letter, 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. 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. It appears that adequate testing was not performed, as your firm could not provide the documents for FDA review, FDA wrote.
 
Accoding to FDA, 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 in the dry room were found contaminated with Bacillus 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 notes effective monitoring and sanitation controls for cosmetic products and control of the processing environment is important to controlling microbiological growth in cosmetic products.
 
For more on the letter, click here.