# FDA 483 - RPC Formatec GmbH - May 27, 2022

Source: https://www.keypedia.com/records/483/rpc-formatec-gmbh/ed56cc57-5760-4e12-9d77-f259176323f7

> FDA 483 for RPC Formatec GmbH on May 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RPC Formatec GmbH
- Inspection Date: 2022-05-27
- Product Type: device
- Office Name: International Compliance Team
- Summary: RPC Formatec GmbH, a manufacturer of device constituent parts for combination products in Mellrichstadt, Germany, was cited for four observations during an FDA inspection. The observations primarily concern inadequate control of non-conforming products, deficiencies in the Design History File for the LupinHaler, ineffective quality audit procedures, and insufficient control over environmental conditions in the cleanroom. These issues indicate significant gaps in the firm's quality system.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/rpc-formatec-gmbh/d81b1463-8207-47ed-8a1c-46e5b0ecfe93

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321