FDA 483 - Pacira Pharmaceuticals, Inc. - March 01, 2018

Pacira Pharmaceuticals, Inc. in San Diego, CA, received a Form 483 with six observations during an inspection from February 21 to March 1, 2018. The observations primarily concern inadequate investigations into discrepancies, deficiencies in cleaning and maintenance procedures, insufficient laboratory controls for microbial identification, and failures in supplier qualification and aseptic processing controls. The firm also failed to follow its own procedures for auditing critical and non-critical suppliers.