# FDA EIR - Cambrex Profarmaco Milano Srl - November 11, 2022

Source: https://www.keypedia.com/records/eir/cambrex-profarmaco-milano-srl/921bbfb4-4c94-4340-bea6-ba05ace69fab

> FDA EIR for Cambrex Profarmaco Milano Srl on November 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Cambrex Profarmaco Milano Srl
- Inspection Date: 2022-11-11
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA inspection report details a post-approval audit of Cambrex Profarmaco Milano Srl, an active pharmaceutical ingredient (API) manufacturer, conducted from November 7 to November 11, 2022. The inspection was performed under Compliance Program 7356.843 (Post-Approval Audit Inspection), focusing on verifying change controls for manufacturing process modifications, commercial batch history, and laboratory testing. Notably, the inspection concluded without the issuance of an FDA-483, indicating no formal written observations of regulatory non-compliance. A single verbal observation was discussed with the firm's management during the close-out meeting, concerning a specific step in the manufacturing process. Overall, the facility continues to operate as an API manufacturer. The inspection outcome was classified as "No Action Indicated (NAI)," meaning no regulatory actions are required from the company based on this inspection. The report recommends re-inspection as part of future assignments, a standard practice for ongoing oversight. No samples were collected, and no refusals were encountered during the inspection.

## Related Documents

- [483 - 2017-05-15](https://www.keypedia.com/records/483/cambrex-profarmaco-milano-srl/98492161-19f3-4b0d-b291-07625e7fcc66)
- [EIR - 2022-11-11](https://www.keypedia.com/records/eir/cambrex-profarmaco-milano-srl/6dcb380c-1dff-43ee-aca6-6b78c06bc4f8)

## Related Officers

- [Investigator](https://www.keypedia.com/people/douglas-c-kovacs/2fd80a0c-1314-4eb0-a14b-c98e65bade81)
- [investigator](https://www.keypedia.com/people/monika-borkowska/4dedee7d-7b93-4f1b-be3b-17ab41e5c0ff)

Company: https://www.keypedia.com/companies/cambrex-profarmaco-milano-srl/5855fd12-020f-4975-9bc0-f5358c581aef

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