American Antibiotics, Inc. – FDA EIR, Dec 18, 2015

An FDA pre-approval inspection of American Antibiotics, Inc. in Baltimore, MD, was conducted from December 14 to December 18, 2015. The inspection, carried out under current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 211), focused on a non-sterile human beta-lactam antibiotic powder drug manufacturer. During the inspection, the company was issued a seven-item FDA Form 483, detailing significant violations. Key issues included severe data integrity deficiencies in the laboratory, such as analysts having administrative access to edit test methods and the lack of audit trail reviews. The quality control unit was found deficient in approving and detecting discrepancies in essential procedures and had unapproved job descriptions for key management roles. Storage procedures were not followed, with different materials co-located on pallets and R&D materials mixed with commercial stock, a repeat observation from a previous inspection. Furthermore, the company improperly invalidated an out-of-specification (OOS) cleaning swab result without proper justification or documentation of corrective actions, and laboratory personnel failed to adhere to established test procedures during dissolution testing. Finally, obsolete labels for unapproved products were found on the packaging line, indicating a failure to destroy outdated materials. Management committed to addressing these observations and submitting a written response within 15 business days. The FDA warned that failure to implement timely corrections could lead to further regulatory action, including a warning letter or import detention. Notably, previous violations from the 2014 inspection regarding facility maintenance and cleaning procedures were verified as corrected.