Starion Instruments – FDA Warning Letter, Feb 25, 2010
On August 10, 2010, the FDA issued a Warning Letter to Starion Instruments Corp. following an inspection from February 8-25, 2010. The inspection revealed that the firm's thermal cutting, cautery, and vessel sealing devices, including the TLS 3 and TLS 4, were adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).
Key violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: Corrective action reports were not generated for identified product quality problems (Correction Removal numbers 9 and 10), as required by SOP 1401 Revision B. 2. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: The "Comment/Complaint Handling" SOP 1403 Revision F lacked instructions for the "Scrub report" (FRM0052), which could identify product complaints. For example, Scrub Report SCR 0955, detailing performance issues, did not generate a complaint.
The firm's March 31, 2010, response was
ID · 71cab26b-32b0-4485-980e-ce07527fa4e5
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