American Contract Systems gets 15 days to show FDA it's cleaned up its act

The FDA sent a warning letter Dec. 3 to American Contract Systems, a medical devicemaker and contract sterilizer, sayings its facility in Houston failed to validate its sterilization operations. 

The FDA inspected the Houston facility  — which sterilizes surgical trays and kits used in hospitals — from Sept. 9 to Oct. 4 and said it found several violations that the facility has yet to correct. 

The letter says that between 2017 and 2019, the facility received 12 complaints about the products it sterilized, and six of the complaints were related to bugs found inside surgical kits. In one case, a bug delayed a patient's surgery. 

The letter also says the facility has failed to prove that all of the devices it sterilizes — including catheters, suction tubing and gowns — can withstand its sterilization process. 

The agency wrote that the violations it found at the facility "may be symptomatic of serious problems in your firm’s manufacturing and quality management systems."

The FDA warned that if the facility fails to send the agency proof that it is working to correct the violations, it could take regulatory action without notice, including seizure, injunction and civil money penalties. Requests for certificates to foreign governments the facility may send the FDA also will not be granted until the violations have been corrected. 

The agency is giving the company 15 days to send documents proving it is taking steps to correct the violations and detail plans to prevent their recurrence.

Read the full letter here

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