# FDA 483 - Boiron Inc. - October 25, 2021

Source: https://www.keypedia.com/records/483/boiron-inc/3dee1892-59c6-4588-871c-7cfdcba49c42

> FDA 483 for Boiron Inc. on October 25, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boiron Inc.
- Inspection Date: 2021-10-25
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Boiron Inc., a homeopathic drug manufacturer in Newtown Square, PA, was cited for significant deficiencies in quality control and testing during an FDA inspection. Observations included failure to verify supplier component reliability, lack of stability studies for drug products, inadequate quality unit oversight, absence of finished product release testing, and neglected annual inspection of reserve samples. These issues indicate a systemic breakdown in ensuring product quality and compliance with manufacturing standards.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/boiron-inc/502403cd-f15f-4cf9-8bc2-70e99a8749b4

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8