# FDA 483 - Icrom Spa - March 18, 2019

Source: https://www.globalkeysolutions.net/records/483/icrom-spa/b760db23-c026-43f3-8869-e098a0ad8b1c

> FDA 483 for Icrom Spa on March 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Icrom Spa
- Inspection Date: 2019-03-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Icrom S.p.A, an API manufacturer in Concorezzo, Italy, revealed 10 observations concerning significant deficiencies in their manufacturing and quality control systems. Key issues included inadequate cleaning procedures, lack of proper quality unit oversight, poor documentation practices, and insufficient investigation of discrepancies. These findings indicate a potential risk to product quality and purity due to a lack of robust controls.

## 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/icrom-spa/ed174b34-7da3-45e4-9688-feb731875ff6

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