FDAnews Device Daily Bulletin

Trinity Sterile Dinged Over Audits, Record-Keeping

Aug. 4, 2017

Trinity Sterile was cited for lack of quality audits, equipment maintenance, and incomplete device history records.

The agency issued a Form 483 after a February-March inspection of the firm’s Salisbury, Md., facility. Investigators found the company did not sufficiently detail the maintenance process for several pieces of equipment and machinery, including sealing machines, HVACs and air compressors, boilers and sterilizers.

The agency also found 18 of 40 2015 audit “elements” where the audit was left incomplete, and none of the 2016/2017 audits were closed.

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