The FDA cited Cook Pharmica over the drug manufacturer’s testing procedures, contamination safeguards and computer systems validations.
FDA officials issued a Form 483 after inspecting Cook’s Bloomington, Indiana, facility between February 13 and 17.
The firm disregarded its procedures aimed at preventing microbial contamination, the agency said. For example, the facility’s process simulation used to test anti-contamination procedures did not accurately replicate the manufacturing process.
The agency also cited the firm’s laboratory controls, which lacked testing procedures to assure all in-process materials met the quality standards. For instance, product samples intended for quality control laboratory testing were placed at numerous access points without temperature monitoring or specified time limits.