FDA 483 - Actavis Laboratories FL, Inc. - April 18, 2006

The FDA Form 483 details multiple observations from an inspection, highlighting significant deficiencies in the facility's quality control, manufacturing processes, equipment maintenance, and investigation procedures.

**Observation 1** notes the Quality Control Unit (QCU) lacks authority and failed to adequately review production records, leading to the release of six batches of Ketoprofen ER capsules (March-July 2005) manufactured with an unvalidated and variable process. The QCU also failed to ensure adequate investigation, documentation, and trending of Phase I Laboratory Investigations after they were moved to a manual logbook in September 2005.

**Observation 2** states that control procedures are not established to validate manufacturing processes causing variability in in-process material and drug product characteristics, citing the QCU's approval of a Ketoprofen process validation protocol in February 2005.

**Observation 3** identifies the use of instruments not meeting specifications. The QCU determined the need to replace flow rate valves in dissolution apparatuses due to frequent problems and erratic results. Despite valves being received in January 2006, they were not installed, and potentially malfunctioning baths continued to be used for various drug products (Cartia, Diltia, Taztia, Metformin, Naproxen Sodium, Ketoprofen). An investigation by the Metrology Department identified crystal deposits as a root cause, recommending more frequent maintenance, but these actions were not implemented. The firm also