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# API Deviations Seen in Fagron Group Inspection
- URL: https://www.fdaweb.com/api-deviations-seen-in-fagron-group-inspection/
- Published: 2022-06-28T12:00:00.000Z
- Updated: 2026-09-14T17:50:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152180

An 11/1-11/18/21 FDA inspection at the Fagron, Inc., drug manufacturing facility in St. Paul, MN, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 6/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fagron-group-bv-624255-06142022?ref=fdaweb.com) says specific violations were:

- failing to perform repackaging of API under appropriate CGMP to avoid potential cross-contamination;
- failing to adequately investigate and document out-of-specification results and implement appropriate corrective actions; and
- failure of the firm’s quality unit to exercise its responsibility to ensure the APIs manufactured at the facility comply with CGMP.

FDA strongly recommends the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. Fagron was told to respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.