FDA sent a warning letter to contract sterilizer American Contract Systems after finding its Houston, Texas facility noncompliant with good manufacturing practices, the agency disclosed Tuesday.
Regulators claimed ACS failed to adequately validate sterilization operations and establish procedures for monitoring and controlling process parameters.
The warning letter is the latest in a series of sterilization-focused warning letters and comes amid closures of facilities on public health grounds.
FDA inspectors reportedly visited ACS, which sterilizes surgical trays and kits for hospital use, over a roughly one-month period starting in September. The inspectors came away with concerns about ACS' compliance with good manufacturing practices, leading them to raise the issues with the company. FDA said ACS failed to get a reply detailing its corrective actions to the agency in time, leading FDA to respond by sending a warning letter last month.
The warning letter lists five areas in which FDA said ACS is failing to comply with regulations. The list is topped by the claim ACS has failed to adequately validate its sterilization operations.
FDA inspectors reached that conclusion after finding the packs ACS used to validate its sterilization procedures lacked components it processed routinely in its actual operation. Other issues included the failure to put devices inside assembled surgical trays for sterilization validating, thereby limiting ACS' ability to determine the effectiveness of its procedure.
There are signs the alleged sterilization failings are affecting product quality. From 2017 to 2019, ACS received six complaints about the presence of foreign matter in sealed sterilization bags, according to the letter. In one case, the foreign matter delayed a scheduled surgery. ACS received 12 complaints in total during that time period.
FDA's specific requests for ACS include the submission of validation documents supporting sterility claims and the provision of evidence that lots distributed by ACS met process parameters.
FDA has issued the warning letters against a backdrop of separate problems for companies that need to sterilize medical devices. Experts fear facility closures triggered by concerns about the release of ethylene oxide, a carcinogen, could result in a shortage of medical devices. FDA has responded to the situation by encouraging adoption of methods that reduce ethylene oxide use.