FDA 483 - Total Pharmacy Services, Inc. - May 22, 2013

The FDA Form 483 details numerous deficiencies at a facility producing sterile drug products from non-sterile components. Aseptic processing areas lack adequate environmental monitoring, with smoke studies not dynamic or videotaped, and surface/air monitoring of ISO 5 environments, along with personnel fingertip sampling, not conducted daily. Pressure differentials have not been monitored since July 25, 2012.

Sterilization processes are not validated; specifically, a redacted filter used for injectable products lacks qualification for bacterial retention and physical/chemical compatibility, and integrity testing documentation is absent. Personnel wear non-sterile cloth gowns and face masks. Procedures for preventing microbiological contamination are deficient: media fills do not simulate actual production, and employees were observed placing materials directly on ISO 5 surfaces without sanitization and resting non-sterile gown-covered arms on the work surface.

Cleaning and disinfection procedures are inadequate; a sporicidal agent's use frequency is not specified or documented, and non-sterile wipes are used in the ISO 5 environment. Each batch of sterile drug product is not tested for sterility or endotoxin. Potency analysis is not conducted on any injectable product. There is no written stability program, lacking scientific data for the three-month beyond-use date assigned to all injectable sterile products.

Raw material testing is insufficient; no additional testing is performed, and suppliers are not qualified to verify Certificates of Analysis. Complaint handling procedures are deficient: a complaint from April 201