# FDA 483 - Cambrex Profarmaco Milano Srl - May 15, 2017

Source: https://www.keypedia.com/records/483/cambrex-profarmaco-milano-srl/98492161-19f3-4b0d-b291-07625e7fcc66

> FDA 483 for Cambrex Profarmaco Milano Srl on May 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cambrex Profarmaco Milano Srl
- Inspection Date: 2017-05-15
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Cambrex Profarmaco Milano S.r.l., an API manufacturer in Paullo, Milano, Italy, was cited for multiple deficiencies during an FDA inspection. Key issues include inadequate investigations into discrepancies and out-of-specification results, poor laboratory controls for reference standards and testing, and insufficient computer system controls. Other concerns involved facility maintenance, lack of stability testing, deficient cleaning procedures, and inadequate component testing.

## Related Documents

- [EIR - 2022-11-11](https://www.keypedia.com/records/eir/cambrex-profarmaco-milano-srl/6dcb380c-1dff-43ee-aca6-6b78c06bc4f8)
- [EIR - 2022-11-11](https://www.keypedia.com/records/eir/cambrex-profarmaco-milano-srl/921bbfb4-4c94-4340-bea6-ba05ace69fab)

## Related Officers

- [Temar Q. Williams](https://www.keypedia.com/people/temar-q-williams/624784fb-dd87-482b-9e8c-a6d79736b132)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd