# FDA 483 - NerPharMa S.r.l. - June 19, 2024

Source: https://www.globalkeysolutions.net/records/483/nerpharma-srl/665c1740-e571-418a-a5d0-7f768a20b6ee

> FDA 483 for NerPharMa S.r.l. on June 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NerPharMa S.r.l.
- Inspection Date: 2024-06-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of NerPharMa S.r.l. in Nerviano, Milan, revealed significant deficiencies across multiple areas of drug manufacturing. The firm failed to establish and follow procedures for preventing microbial contamination, adequately monitor environmental conditions, and ensure proper in-process specifications. Additional issues included inadequate cleaning validation, equipment design, quality control unit procedures, employee training, and batch record documentation.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ruo-h-xu/cd7df486-187e-41a2-b424-434fa8b80648)
- [Daniel L Obstut](https://www.globalkeysolutions.net/people/daniel-l-obstut/4db3cc0f-a01b-4f68-ae35-c472ae732747)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.globalkeysolutions.net/companies/nerpharma-srl/12f11f8a-e70e-4598-807c-a1571bab0391

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1