FDA 483 - franck's lab inc - May 23, 2014

The FDA inspection of a drug manufacturing facility revealed multiple deficiencies across its aseptic processing areas and quality systems. The facility's ISO 7 clean room and ISO 8 ante-room had unsealed ceiling tiles, visible tears in two ISO 7 ceiling tiles (one porous), and walls that were not smooth or easily cleanable. Flaking paint and rust were observed on an ISO-5 laminar flow hood bench. The impact of ongoing remodeling on ISO 7 clean room airflow was not assessed, nor was a risk assessment performed for potential product contamination.

The ISO 7 clean room contained inappropriate items like a radio, computer monitor, cardboard boxes, and a piece of wood. Dead insects were found on light panels above the ISO 5 laminar flow hood and the ante-room. Procedures to prevent microbiological contamination were not established. A pharmacy technician handled elastomeric infusion devices with bare hands before hand washing/gowning and without sanitization. These devices were later transferred to the ISO-5 processing bench without a sanitization step. Compounding instructions for Vancomycin were incomplete, lacking proper aseptic technique.

Cleaning and disinfecting procedures were deficient. ISO 5 surfaces were cleaned only with one solution, lacking a cleanser or sporicidal disinfectant. Conflicting written work instructions existed for sanitizers. A disinfectant bottle in use was over one year past its expiration date. Laminar flow hoods were relocated, potentially obstructing airflow, and the ISO 7 clean room was not qualified under these new conditions.