# FDA 483 - Hameln RDS S.R.O. - August 05, 2022

Source: https://www.globalkeysolutions.net/records/483/hameln-rds-sro/75b8c824-80a0-432c-b108-7e6efdb6e1bd

> FDA 483 for Hameln RDS S.R.O. on August 05, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hameln RDS S.R.O.
- Inspection Date: 2022-08-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hameln RDS A.S., an API manufacturer in Modra, Slovakia, identified significant deficiencies within its quality control unit. The firm failed to adequately follow written procedures for deviation control, including timely notification and proper root cause identification. Additionally, critical process parameters were not properly evaluated, documented, or monitored during manufacturing operations.

## Related Officers

- [Retired](https://www.globalkeysolutions.net/people/ariel-cruz-figueroa/c6ade050-dbe1-4aa3-b88f-980db51b88b0)

Company: https://www.globalkeysolutions.net/companies/hameln-rds-sro/b2488708-6cbc-451b-8879-1b2cffbde8ce

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