# FDA WARNING_LETTER - Fagron Group B.V. - November 18, 2021

Source: https://www.keypedia.com/records/warning_letter/fagron-group-bv/95856957-c030-486e-ba8e-cfcc801023b0

> FDA WARNING_LETTER for Fagron Group B.V. on November 18, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Fagron Group B.V.
- Inspection Date: 2021-11-18
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA issued a Warning Letter to Fagron, Inc. following an inspection from November 1 to November 18, 2021, at their Saint Paul, Minnesota facility, identifying significant deviations from Current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (API).

Key violations include:
1.  **Failure to prevent cross-contamination during API repackaging:** The firm lacked adequate cleaning validation studies for non-dedicated production rooms and equipment, with preliminary results showing unacceptable residue levels for potent compounds like niacin and progesterone. Visible powder residue was observed on equipment after cleaning, and a cleaning log was destroyed.
2.  **Inadequate investigation of out-of-specification (OOS) results:** The firm failed to investigate OOS bioburden counts in their water system, a drug component, exceeding action limits. Investigations into OOS results were not initiated or adequately documented.
3.  **Quality Unit (QU) deficiencies:** The QU failed to ensure CGMP compliance, with laboratory equipment allowing unrestricted data changes/deletion and a lack of qualification for contract laboratories, a repeat observation from 2017.

The FDA requires comprehensive corrective actions, including a retrospective assessment of cleaning effectiveness, a CAPA plan for cleaning processes, improvements to the cleaning validation program, updated SOPs, and testing of retain samples for cross-contamination. For OOS issues, a retrospective review of invalidated OOS results, a comprehensive review and remediation plan for OOS investigation

## Related Officers

- [Associate Director](https://www.keypedia.com/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)
- [Belen Perez](https://www.keypedia.com/people/belen-perez/e3c9cdee-f603-46c0-af60-b2e4f49c07e1)

Company: https://www.keypedia.com/companies/fagron-group-bv/91269466-2c12-4d1c-8047-b28342ed8bd3

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0