FDA WARNING_LETTER - DPT Lakewood, LLC - March 07, 2012

The FDA issued a Warning Letter to OPT Lakewood, LLC, following a February 15 to March 7, 2012, inspection of their Lakewood, NJ pharmaceutical manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug product, Santyl Ointment, adulterated.

Key violations include inadequate investigations into sterility failures of multiple Santyl Ointment lots (007885, 007856, 100329, 100336, 200005, 200006, P905331H) and a media fill conducted in June 2011. The firm's investigations often attributed failures to contract laboratories or operator aseptic technique, but subsequent failures or lack of supporting evidence contradicted these conclusions. The FDA noted that corrective actions like re-training operators and conducting media fills have been insufficient to control microbial contamination.

Additionally, the firm failed to establish appropriate written procedures to prevent microbiological contamination of sterile drug products (21 CFR 211.113(b)), evidenced by multiple organism detections and 6 out of 40 manufactured Santyl Ointment lots failing sterility release testing since November 2010.

The FDA requires a comprehensive evaluation of sterile drug