# FDA 483 - Intercos Europe S.p.A - March 15, 2024

Source: https://www.globalkeysolutions.net/records/483/intercos-europe-spa/dca1ae64-c7cb-47a4-9946-984afd4d107f

> FDA 483 for Intercos Europe S.p.A on March 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intercos Europe S.p.A
- Inspection Date: 2024-03-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Intercos Europe S.p.A, an OTC drug manufacturer in Agrate Brianza, Italy, revealed significant deficiencies in quality control and manufacturing practices. Observations included inadequate testing of components, lack of scientific justification for sampling methods, and incomplete investigations into microbiological excursions and batch record discrepancies. The firm also failed to maintain complete laboratory records and adequately document equipment cleaning procedures, with one observation being a repeat finding from a previous inspection.

## Related Documents

- [WARNING_LETTER - 2024-03-15](https://www.globalkeysolutions.net/records/warning_letter/intercos-europe-spa/91f49e1e-1f26-4045-8506-0f8cd2d7cf9f)

## Related Officers

- [Joseph A. Piechocki](https://www.globalkeysolutions.net/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)

Company: https://www.globalkeysolutions.net/companies/intercos-europe-spa/d0e271a6-ff7f-494e-a45b-ef3994a32e5a

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