FDA 483 - well care discount pharmacy llc - May 12, 2016

The FDA Form 483 details numerous deficiencies at a firm producing sterile injectable drug products. Key issues include a lack of documented smoke studies for unidirectional airflow in the ISO 5 (b)(4) and improper (b)(4) performance for all sterile injectable drug batches, impacting sterility assurance for approximately (b)(4) batches. The Lab Manager was observed repeatedly blocking HEPA unidirectional airflow and touching product contact surfaces of sterile stoppers.

Gloves used for sterile processing were inadequately disinfected, appearing sticky. The ISO 5 (b)(4) had exposed, shedding wood-like material, and the ISO 8 clean room had laminated particle board surfaces and a ceiling with gaps and unsecure caulking, with these areas not routinely cleaned. Components and materials were transferred to the ISO 5 (b)(4) without proper disinfection. Non-sterile APIs and excipients were weighed and mixed in a non-ISO classified area, with visibly stained and dirty equipment.

The firm failed to adequately perform sterility and endotoxin testing on sterile products, with significant gaps in testing since January 2016. Sterility tests performed by a contract lab were not compliant with compendial standards. Combination products lacked sterility, endotoxin, or potency testing. Potency testing was also limited.

Clean room pressure differential was not monitored, and environmental and personnel monitoring were not performed daily. Growth promotion was not performed for all media lots, and media suitable for yeast and mold detection