FDA 483 - Meridian Medical Technologies, Inc. - April 29, 2013

The FDA Form 483 details numerous deficiencies at a drug manufacturing facility, primarily concerning the Quality Unit and its oversight. The Quality Unit lacked authority to review production records, investigate errors, and adequately review qualification reports (OP 13-610, QP13-110). It failed to ensure adequate employee training, particularly for ATNAA remediation.

Several instances of unreported or delayed Field Alert Reports (FARs) were cited. Missing Pralidoxime Chloride in ATNAA lots 2M1645 and 2M1644 was not reported until March 15, 2013, despite being identified in February 2013. Missing Atropine in ATNAA lot 1M1591 (September 2011) was never reported. A faulty safety pin in ATNAA lot 2M1645 led to the discovery of the same issue in distributed lot 2M1536, resulting in a quarantine, but no FAR was submitted.

The Quality Unit failed to identify root causes in investigations, expand investigations to affected lots, and approve the movement of drug product reserve samples. It also failed to evaluate the appropriateness of study amounts and investigate incorrectly packaged DuoDote Injectable Product (lot 2AE8781).

Further issues include inadequate employee training, failed qualification and process validation protocols due to unaccounted-for units,