# FDA 483 - Actavis Italy Spa A Socio Unico - March 15, 2019

Source: https://www.globalkeysolutions.net/records/483/actavis-italy-spa-a-socio-unico/742c91d8-4547-40c4-8285-112e40ea800e

> FDA 483 for Actavis Italy Spa A Socio Unico on March 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Actavis Italy Spa A Socio Unico
- Inspection Date: 2019-03-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Actavis Italy S.p.A. in Nerviano, Milan, was inspected and received a Form 483 with six observations primarily concerning manufacturing controls, laboratory procedures, and record-keeping. Issues included inadequate equipment cleaning and design, failure to follow sterile product procedures, and deficiencies in stability testing and laboratory documentation. These observations indicate significant concerns regarding the firm's adherence to good manufacturing practices and quality control.

## Related Officers

- [Philip F. Istafanos](https://www.globalkeysolutions.net/people/philip-f-istafanos/c2fcfe52-1070-4551-bffc-f8bcfad5b30b)
- [Supervisory Consumer Safety Officer, China Office](https://www.globalkeysolutions.net/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)

Company: https://www.globalkeysolutions.net/companies/actavis-italy-spa-a-socio-unico/7c4ac702-d647-4c5d-a853-472db165127e

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