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

Source: https://www.keypedia.com/records/eir/cambrex-profarmaco-milano-srl/6dcb380c-1dff-43ee-aca6-6b78c06bc4f8

> 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
- Summary: An FDA Post-Approval Inspection (PoAI) of Cambrex Profarmaco Milano Srl, an active pharmaceutical ingredient (API) manufacturer, was conducted from November 7 to November 11, 2022. The inspection, part of a foreign inspection trip, was performed under Compliance Program 7356.843 (Post-Approval Audit Inspection). Its purpose was to verify activities such as change controls for manufacturing process modifications, commercial batch history, and laboratory testing. Notably, no formal observations (FDA-483) were issued during this inspection, nor during the previous inspection in May 2019. One minor verbal observation regarding a specific manufacturing step was discussed with the firm's management. The inspection concluded with a "No Action Indicated" (NAI) classification, meaning no immediate corrective actions are mandated. The facility is scheduled for re-inspection as per future assignments.

## 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/921bbfb4-4c94-4340-bea6-ba05ace69fab)

## 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