Keystone Laboratories Inc – FDA Warning Letter, Aug 29, 2012

The FDA issued a Warning Letter to Keystone Laboratories, Inc. following an August 2012 inspection of their Memphis, TN pharmaceutical manufacturing facility, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211). These violations render their drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key CGMP violations include: 1. Failure to maintain buildings in good repair (e.g., leaking condensate, peeling paint), a repeat observation from 2009 and 2011 inspections. 2. Use of inappropriate equipment (e.g., wooden sticks, cardboard covers) that are difficult to clean and can contaminate products. 3. Failure to clean and maintain equipment at appropriate intervals, with observations of scratches, rust, visible buildup, and lack of cleaning documentation, also a repeat observation from 2009 and 2011. 4. Failure to test and release components, specifically water used in drug products, for microbiological contamination and lack of water system validation, a repeat observation from 2011. 5. Failure to follow written production and process control procedures, including lack of secondary verification for critical steps like component weight dispensing.

Additionally, several products marketed as cosmetics were deemed unapproved and/or misbranded drugs under Sections