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21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
21 CFR 211.134(b). Representative samples after completion Samples of representative units were not collected and visually examined for correct labeling at the completion of finishing operations.
21 CFR 211.42(c)(10)(iii). Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
FDCA 503B(a)(10). Drug product label, outsourcer facility The labels of your outsourcing facility's drug products are deficient.
Official Action Indicated (OAI)
Feb 8, 2018
Drugs · Drug Quality Assurance
5 cited references
FDCA 501(a)(2)(A). Inadequate HEPA filter, sterile product area You had inadequate HEPA filter coverage and airflow over the area to which sterile product was exposed.
FDCA 501(a)(2)(A). Disinfecting and cleaning agents, ISO 5 area Disinfecting agents and cleaning pads and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
FDCA 501(a)(2)(A). Beta-lactam drugs, inadequate sanitation You produced beta-lactam drugs without providing adequate cleaning of utensils to prevent cross-contamination.
FDCA 501(a)(2)(A). Non-microbial contamination, production area Non-microbial contamination was observed in your production area.
FDCA 501(a)(2)(A). Disruption of airflow from personnel movement Personnel moved rapidly in the vicinity of open sterile units and instruments, which disrupted the airflow and increased the risk of bringing lesser quality air into the ISO 5 classified aseptic processing area.
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Woburn, Massachusetts, United States. Part of