# FDA 483 - Fehling Instruments GmbH & Co. KG - August 04, 2022

Source: https://www.keypedia.com/records/483/fehling-instruments-gmbh-co-kg/fa98724b-03ff-468d-8cf0-199a4ce34b2f

> FDA 483 for Fehling Instruments GmbH & Co. KG on August 04, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fehling Instruments GmbH & Co. KG
- Inspection Date: 2022-08-04
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Fehling Instruments GmbH & Co. KG, a medical device manufacturer in Karlstein, Germany, was inspected by the FDA from August 1-4, 2022. The inspection revealed that the firm's procedures for controlling nonconforming products were not adequately established. This indicates a significant issue with the firm's quality system regarding product control.

## Related Documents

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## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/fehling-instruments-gmbh-co-kg/5de69c57-56e8-4569-8e3e-8816ce90532e

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd