# FDA WARNING_LETTER - Ortho Clinical Diagnostics Gmbh - February 12, 2015

Source: https://www.globalkeysolutions.net/records/warning_letter/ortho-clinical-diagnostics-gmbh/6e20c186-c908-423e-b648-bae5e26c483b

> FDA WARNING_LETTER for Ortho Clinical Diagnostics Gmbh on February 12, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ortho Clinical Diagnostics Gmbh
- Inspection Date: 2015-02-12
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On September 3, 2015, the FDA issued a Warning Letter to Ortho-Clinical Diagnostics GmbH, a refurbishment facility for Class II Clinical Chemistry and Immunodiagnostics equipment in Neckargemund, Germany, following an inspection from February 9-12, 2015. The inspection revealed that the firm's devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The firm failed to adequately document effectiveness checks for four specific CAPAs (2013-001, 2013-002, 2013-005, 2013-003). The firm's response was inadequate as it did not address local paper processes, language requirements, or provide justification for limited retrospective reviews and revised procedures/training.
2.  **Failure to control nonconforming product (21 CFR 820.90(a))**: The firm failed to adequately investigate and document details of potentially affected products (chemicals, lot numbers, quantities) for nonconformance events #337393 and #20

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/alberto-gutierrez/ec16aa77-9dd3-4aff-aae4-1540ea96c5b8)
- [Jennifer Paine](https://www.globalkeysolutions.net/people/jennifer-paine/a0728c59-7cb5-453a-8f61-845da4780b30)

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-gmbh/0300cc1a-6e71-4869-b2e6-4e526cbdaaa2

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