The FDA cited OTC and prescription drugmaker Woodfield Pharmaceutical of Houston, Texas for non-compliant batch reviews, complaint handling and quality control at its facility.
The agency’s inspection between Aug. 21 and Oct. 3, 2018 uncovered bacterial contamination in samples of finished product in a manufacturing room dating from May to July. The firm continued to manufacture lots in the room between those months and released them for distribution. The quality control unit failed to document a CAPA for the contamination until Sept. 18, 2018 — and the plan was not implemented at the time of the inspection.
After reviewing the firm’s interim report for validating its upgraded water purification systems, the agency discovered that the facility failed to investigate the presence of B. cepacia — a pathogen known to cause infections in hospitals — in a manufacturing room.