FDA WARNING_LETTER - Concept Laboratories, Inc. - January 18, 2008

An FDA inspection of Concept Laboratories, Inc. from December 12, 2007, to January 18, 2008, revealed significant deviations from cGMP regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals, rendering their drugs adulterated per 21 U.S.C. 351(a)(2)(B). The firm also manufactures unapproved new drugs and misbranded drugs, violating 21 U.S.C. 352(a), 352(c), 352(e), and 355(a).

Key cGMP deviations include: 1. **Failure of Quality Control Unit (QCU) to investigate out-of-specification (OOS) results:** Numerous OOS results for Skin Lightening Creme/Lotion and Pain Relief Creme were not investigated, contrary to the firm's SOP. The firm's reliance on long-term stability results for release criteria and misunderstanding of process validation were noted. 2. **Failure to establish written production and process control procedures:** No process validation studies were conducted for human drug products. The firm's response lacked a timeline for proposed validation. 3. **Failure to follow written production and process control procedures:** Deviations from mixing times in batch records (e.g., EMU Essentials Pain Relieving Cream, Anti-Aging Skin Light