# FDA 483 - Herbamed AG - September 11, 2023

Source: https://www.keypedia.com/records/483/herbamed-ag/0b80c79c-1a60-4fb3-82a1-415939a19e14

> FDA 483 for Herbamed AG on September 11, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Herbamed AG
- Inspection Date: 2023-09-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Herbamed AG, a homeopathic API manufacturer in Bühler, Switzerland, identified three significant observations. The firm failed to perform annual Product Quality Reviews for multiple APIs shipped to the U.S., a repeat observation from previous inspections. Additionally, stability testing was not performed for a specific API lot, and numerous change controls initiated between 2015-2018 remained unclosed.

## Related Officers

- [CDR Carl A. Huffman III](https://www.keypedia.com/people/cdr-carl-a-huffman-iii/c795e3ce-de9a-4567-9bdb-99ba9ac4731a)

Company: https://www.keypedia.com/companies/herbamed-ag/d4987d1a-9073-4e45-ba78-0c4fe49241ef

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