# FDA 483 - Dr Franz Koehler Chemie Gmbh - April 11, 2024

Source: https://www.keypedia.com/records/483/dr-franz-koehler-chemie-gmbh/a0944b35-2607-4e5b-befb-ac21d172c354

> FDA 483 for Dr Franz Koehler Chemie Gmbh on April 11, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr Franz Koehler Chemie Gmbh
- Inspection Date: 2024-04-11
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Dr Franz Koehler Chemie GmbH, a manufacturer of Class 2 medical devices, received three observations during an FDA inspection. The firm failed to report a device field corrective and removal action to the FDA within the required 10 days. Additionally, deficiencies were noted in their procedures for design changes and acceptance activities for raw materials and packaging.

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/dr-franz-koehler-chemie-gmbh/614d4deb-e831-45fc-80f2-ea158876d239

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4