# FDA WARNING_LETTER - Syntron Bioresearch Inc. - January 21, 2010

Source: https://www.keypedia.com/records/warning_letter/syntron-bioresearch-inc/c675c7e7-91c9-447e-aa11-60b1b22bfc6e

> FDA WARNING_LETTER for Syntron Bioresearch Inc. on January 21, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Syntron Bioresearch Inc.
- Inspection Date: 2010-01-21
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On May 24, 2010, the FDA issued a Warning Letter to Syntron Bioresearch Inc. following an inspection from January 11-21, 2010. The inspection found that Syntron's drug abuse test kits, classified as devices, were adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) Good Manufacturing Practice (CGMP) requirements.

Key violations included:
1. **Process Validation (21 CFR 820.75(b)):** Failure to identify process parameters for lyophilization.
2. **Complaint Handling (21 CFR 820.198(c)):** Inadequate investigation of customer complaints regarding wrong pipettes, ink spots, migration failures, and incorrect package inserts.
3. **Nonconforming Product (21 CFR 820.90(a)):** Failure to control nonconforming product, a repeat observation, with rejected raw materials released to the warehouse without proper documentation.
4. **Acceptance Activities (21 CFR 820.80(e)(3)):** Inadequate documentation of incoming product acceptance, lacking measurements and test results.
5. **Incoming Product Acceptance (21 CFR 820.80(b)):** No

## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)
- [Director](https://www.keypedia.com/people/blake-bevill/7ed0dcde-28a7-452b-870d-6e085580abde)
- [Raymond W. Brullo](https://www.keypedia.com/people/raymond-w-brullo/c3500ac9-8d22-4c49-b416-8786d548eb93)

Company: https://www.keypedia.com/companies/syntron-bioresearch-inc/6c80078a-35a1-4b79-98de-f92f1099728b

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7