FDA WARNING_LETTER - Cantrell Drug Company - November 04, 2013

The FDA issued a Warning Letter to Cantrell Drug Company following an inspection from October 15 to November 4, 2013, which revealed serious deficiencies in sterile drug product manufacturing. The firm failed to demonstrate adequate protection of ISO 5 areas, posing a contamination risk. A Form FDA-483 was issued.

Before registering as a 503B outsourcing facility on December 16, 2013, Cantrell distributed drug products without valid prescriptions for individually-identified patients, rendering them unapproved new drugs (violation of FDCA section 505(a)) and misbranded (violation of section 502(f)(1)) due to inadequate directions for use. These products were also adulterated under section 501(a)(2)(B) due to significant Current Good Manufacturing Practice (CGMP) violations.

Observed CGMP violations included failure to: establish and follow procedures preventing microbiological contamination (21 CFR 211.113(b)); ensure appropriate personnel clothing (21 CFR 211.28(a)); establish adequate environmental monitoring (21 CFR 211.42(c)(10)(iv)); and establish adequate cleaning/disinfecting systems (21 CFR 211.42(c)(10)(v)).

While Cantrell's November 21, 2013,