# FDA WARNING_LETTER - Starion Instruments - February 25, 2010

Source: https://www.globalkeysolutions.net/records/warning_letter/starion-instruments/71cab26b-32b0-4485-980e-ce07527fa4e5

> FDA WARNING_LETTER for Starion Instruments on February 25, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Starion Instruments
- Inspection Date: 2010-02-25
- Product Type: Devices
- Office Name: San Francisco District Office
- Summary: 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

## Related Officers

- [Director ](https://www.globalkeysolutions.net/people/barbara-j-cassens/26dd2da1-417d-4913-9432-3d50fb3c2f40)

Company: https://www.globalkeysolutions.net/companies/starion-instruments/55717e3b-d040-4cfb-858a-84cbb23241ac

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df