# FDA 483 - Pfizer Italia S.r.l. - Unknown Date

Source: https://www.keypedia.com/records/483/pfizer-italia-srl/58d40bf1-74f4-42fe-9275-e3d39d9e2a41

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

---

## Details

- Record Type: 483
- Company Name: Pfizer Italia S.r.l.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Pfizer Italia, SRL in Ascoli Piceno, Italy, a finished drug product facility, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate cleaning validation, failures in quality assurance procedures for drug product identity and purity, an insufficient stability program, and a lack of detailed written procedures for component sampling and storage. These issues indicate a need for improved controls over manufacturing processes and quality systems.

## Related Documents

- [483 - 2018-06-29](https://www.keypedia.com/records/483/pfizer-italia-srl/940302f6-a550-4f4c-b3f0-966d95d2b395)

## Related Officers

- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

Company: https://www.keypedia.com/companies/pfizer-italia-srl/a92f2a05-0dbf-4e6f-a1e6-2c84a0f5db02

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