FDA Hits Glatt on Equipment Cleaning, Quarantining Procedures
Glatt Air Techniques did not properly clean manufacturing equipment and failed to quarantine drug products before release, according to the FDA.
The agency issued a Form 483 after a January inspection of the firm’s Ramsey, N.J, facility, which manufactures drugs.
Officials reported what appeared to be rust, as well as a “darkish-brown material” on the interior lid of a company washing machine used for cleaning product-contaminated material. As the company did not maintain logbooks for its equipment, there was no easy way to verify the washing machine’s usage history, according to the agency.
The inside surface of a dryer lid, meanwhile, contained an “extensive” amount of an unidentified powder. There were no logbooks, so the FDA officials could not verify the equipment’s usage history.