# FDA 483 - NerPharMa S.r.l. - Unknown Date

Source: https://www.keypedia.com/records/483/nerpharma-srl/e21affab-994e-45dc-be40-f9d8af6d093b

> FDA 483 for NerPharMa S.r.l. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NerPharMa S.r.l.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of NerPharMa S.r.l. in Nerviano, Milan, Italy, revealed significant deficiencies in their manufacturing and laboratory operations. Key issues include inadequate procedures for preventing microbiological contamination of sterile drug products, incomplete and unreliable electronic laboratory records, and a failure to thoroughly investigate unexplained discrepancies and batch rejections. The firm also demonstrated shortcomings in personnel training, environmental monitoring, and instrument calibration procedures.

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## Related Officers

- [Susan T. Hadman, Microbiologist](https://www.keypedia.com/people/susan-t-hadman-microbiologist/bf7d4804-bb3e-4a4c-9245-00cd0ebe91e6)
- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

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

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