East Marietta Drug Company – FDA 483, Aug 23, 2019

An FDA Form 483 was issued following an inspection on August 19, 2019, identifying significant deficiencies in the production of highly potent drugs. The facility failed to provide adequate cleaning of work surfaces to prevent cross-contamination. Specifically, during the production of Bi-Est 3 mg/mL Cream (calculated lot #: 08192019@3), no cleaning of work surfaces was observed prior to beginning production of the subsequent drug product, T3 32.5 mcg/T4 175 mcg SR Capsules (calculated lot #: 08192019@2).

Personnel also did not disinfect and change gloves frequently enough to prevent contamination. Despite a technician stating routine sanitization and glove changes between drug products, observations revealed no glove changes between three different drug products: Gabapentin 50mg Capsule Floor Stock Capsule (calculated lot# 08192019@4), Bi-Est 3mg/mL Cream (calculated lot# 08192019@3), and T3 32.5 mcg/T4 175mcg SR Capsules (calculated lot#: 08192019@2). Furthermore, the technician was frequently observed touching personal eyeglasses or a personal cell phone with gloved hands. Non-microbial contamination was also noted in the production area. These observations indicate a failure to