FDA WARNING_LETTER - Skin Sciences Laboratory, Inc. - February 01, 2017

The FDA issued a Warning Letter to Skin Sciences Laboratory, Inc. following a January 30 to February 1, 2017, inspection of their Pasig City, Philippines drug manufacturing facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Lack of Finished Product Testing (21 CFR 211.165(a)):** The firm failed to test drug products for identity and strength of active ingredients prior to release. Their response to create an SOP was deemed inadequate as it did not address distributed lots. The FDA requires a detailed risk assessment for all in-expiry U.S. market products and testing of retain samples for identity and strength. 2. **Failure to Test Raw Materials (21 CFR 211.84(a)):** The firm failed to test glycerin raw material for diethylene glycol (DEG) contamination before use in drug manufacturing, including Essence Skin Saving Toothpaste. Their commitment to implement testing and test remaining stock was inadequate as it did not address distributed lots. The FDA requires a detailed risk assessment for all in-expiry U.S. market products containing glycerin and testing of retain samples for DEG.

Additionally, the firm manufactures and distributes unapproved new drugs and misbranded drugs: *