# FDA 483 - Boiron - November 29, 2024

Source: https://www.globalkeysolutions.net/records/483/boiron/491165fc-44ee-4947-b60b-32ff3b94d174

> FDA 483 for Boiron on November 29, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boiron
- Inspection Date: 2024-11-29
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Boiron, a homeopathic drug manufacturer in Montrevault, France, was cited for significant deficiencies in its microbiological testing methods, environmental monitoring investigations, and cleanroom cleaning and disinfection processes. The inspection revealed inadequate validation of test methods for media, drug solutions, and finished products, as well as a failure to properly investigate environmental monitoring excursions involving pathogens. Additionally, the firm lacked disinfectant efficacy studies and qualification of its cleanroom decontamination process, indicating a high severity of non-compliance in aseptic processing.

## Related Officers

- [Eileen A. Liu](https://www.globalkeysolutions.net/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)
- [Angelica M. Hernandez](https://www.globalkeysolutions.net/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.globalkeysolutions.net/companies/boiron/5a72b640-7ab9-4ece-a38b-c0a90542739a

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8