# FDA 483 - Aptar Radolfzell Gmbh - February 25, 2022

Source: https://www.keypedia.com/records/483/aptar-radolfzell-gmbh/fd9548d3-91de-4c9e-9bac-0e8369f8d9c6

> FDA 483 for Aptar Radolfzell Gmbh on February 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aptar Radolfzell Gmbh
- Inspection Date: 2022-02-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aptar Radolfzell Gmbh, a sterile drug container closure manufacturer in Riegel-Engen, Germany, received a Form 483 for significant quality system deficiencies. The inspection revealed failures in thoroughly investigating discrepancies and out-of-specification results, a lack of written procedures for production and process controls, and inadequate design verification for their Ophthalmic Squeeze Dispenser (OSD) product. These observations indicate a need for improved quality oversight in manufacturing and design processes.

## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Esteban Beltran](https://www.keypedia.com/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.keypedia.com/companies/aptar-radolfzell-gmbh/0fe4cca2-af20-41f8-8ec0-edd859862fc7

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