# FDA WARNING_LETTER - Advanced Testing Laboratory Inc - April 09, 2010

Source: https://www.globalkeysolutions.net/records/warning_letter/advanced-testing-laboratory-inc/73b94f36-c54e-4a49-bcfe-8ebfa6736f6a

> FDA WARNING_LETTER for Advanced Testing Laboratory Inc on April 09, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Advanced Testing Laboratory Inc
- Inspection Date: 2010-04-09
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: During a February-April 2010 inspection, FDA identified significant Current Good Manufacturing Practice (CGMP) violations at Advanced Testing Laboratory, Inc., a pharmaceutical contract testing laboratory. These violations render clients' drug products adulterated. The firm's April 29, 2010, response was deemed insufficient.

Key violations include:
1.  **Unsound Test Procedures (21 CFR §211.160(b))**: Desiccated Agar plates were used for microbial testing, and the firm lacked criteria for personnel contamination in colony counts, potentially leading to inaccurate results.
2.  **Inadequate Instrument Calibration (21 CFR §211.160(b)(4))**: Several instruments were out of calibration or lacked proper maintenance records. Incubators were not properly qualified with heat distribution studies.
3.  **Unvalidated Test Methods (21 CFR §211.165(e))**: The firm performed analytical method transfers for 236 protocols without confirming client method validation.
4.  **Quality Control Unit Deficiencies (21 CFR §211.22(d))**: The QCU failed to fully document and evaluate 946 internal defects, lacking required reports and trend analysis.
5.  **Failure to Follow Procedures (21 CFR §211.160(a))**: Expired USP standards were present, formula

## Related Officers

- [Teresa C. Thompson](https://www.globalkeysolutions.net/people/teresa-c-thompson/b41b98e5-2a7c-4f19-923b-058a197a8fd4)

Company: https://www.globalkeysolutions.net/companies/advanced-testing-laboratory-inc/8641b813-10de-430d-b79e-e97d8be3bdcc

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22