# FDA WARNING_LETTER - Moehs Cantabra, S.L. - December 17, 2010

Source: https://www.keypedia.com/records/warning_letter/moehs-cantabra-sl/be68dc80-306d-4759-b035-868ec118178b

> FDA WARNING_LETTER for Moehs Cantabra, S.L. on December 17, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Moehs Cantabra, S.L.
- Inspection Date: 2010-12-17
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Warning Letter, dated April 14, 2011, addresses Moehs Cantabra, S.L. following a December 13-17, 2010 inspection of their API manufacturing facility in Polanco Cantabria, Spain. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP), rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's January 14, 2011, response was deemed insufficient.

Key violations include:
1.  **Failure to investigate and document out-of-specification (OOS) results:** Specifically, an (b)(4) API lot was released based on a passing retest without investigation after an initial OOS assay result. The firm's justification lacked scientific support.
2.  **Failure to follow approved test procedures:** The firm did not adhere to the required HPLC injection sequence for (b)(4) and (b)(4) assays, and not all injection results were reported for certain lots.
3.  **Incomplete and unreliable laboratory control records:** Raw data for sample and standard weights were missing, with only Excel spreadsheets available. Some HPLC chromatographs were also absent from batch records.
4.  **Inadequate product quality reviews:** The 2008 annual product review for (b)(4) contained discrepancies between reported impurity levels

## Related Officers

- [Director](https://www.keypedia.com/people/richard-l-friedman/2827edf4-7dbd-4430-96b2-87853c27e113)
- [USFDA/Director Division of International Drug Quality/CDER OC](https://www.keypedia.com/people/carmelo-rosa/cfc7c00c-9e11-485e-babe-f7726a7796a7)

Company: https://www.keypedia.com/companies/moehs-cantabra-sl/95495225-16b7-4a28-b39d-e4d5e0442447

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c