Beauty Manufacturing Solutions Corp. FDA Warning (2018)

Detailed Analysis

False Claims and Regulatory Violations

• A comprehensive evaluation of the water system design along with thorough corrective and preventive actions to be taken to install a suitable system.• An effective program for ongoing control, maintenance, and monitoring that ensures the system consistently produces water that meets the purified water USP monograph specifications and appropriate microbial limits. Regarding the latter, it is important to note that total count limits that are significantly tighter than(b)(4)cfu/mL are appropriate for most topical products.• A detailed risk assessment of the potential effects of the observed water system failures on the quality of each of your drug product lots within expiry, and notification to your customers of these significant deviations. This assessment should prioritize review of all

Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.

Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts.

Potential Health Risks

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

This system is fundamentally flawed as it is not capable of producing water that is suitable for use in pharmaceutical manufacture. In your response, you state that bulk product tests met drug product microbiological specifications. Your response is inadequate because quality control testing of a limited sample is insufficient to establish that a product is acceptable. Because microbiological contamination is not uniformly distributed and difficult to detect during testing, it is essential that stringent upstream controls be employed to assure the quality of a batch.

Mark W. RiveroCompliance OfficerU.S. Food and Drug AdministrationOffice of Pharmaceutical Quality Operations, Division II, Compliance Branch4040 North Central Expressway, Suite 300Dallas, Texas 75204.

Regulatory Context

Jin K. Song, Owner and CEOBeauty Manufacturing Solutions Corp.1250 Freeport ParkwayCoppell, Texas 75019-4410

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Beauty Manufacturing Solutions Corp. at 1250 Freeport Parkway, Coppell, Texas (FEI 1610490), from June 19 to 30, 2017.

Because your methods, facilities or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).