Herbamed AGSeptember 11, 2023

FDA 483 - Herbamed AG - September 11, 2023

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Record Details

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.

Company: Herbamed AG
Inspection Date: September 11, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: CDR Carl A. Huffman III

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ID · 0b80c79c-1a60-4fb3-82a1-415939a19e14