# FDA 483 - Hahnemann Laboratories, Inc.,  dba Alpine Pharmaceuticals - January 31, 2025

Source: https://www.globalkeysolutions.net/records/483/hahnemann-laboratories-inc-dba-alpine-pharmaceuticals/3e203b89-ac0a-4401-b2ec-26c4b680f473

> FDA 483 for Hahnemann Laboratories, Inc.,  dba Alpine Pharmaceuticals on January 31, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Hahnemann Laboratories, Inc.,  dba Alpine Pharmaceuticals
- Inspection Date: 2025-01-31
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals in San Rafael, CA, was cited with three observations during an FDA inspection. The inspection revealed significant issues including the failure to validate microbial testing methods, inadequate quality control unit procedures and investigation practices, and a lack of qualification for a third-party component supplier. These deficiencies indicate a systemic breakdown in quality assurance for their homeopathic drug products.

## Related Documents

- [483 - 2020-01-28](https://www.globalkeysolutions.net/records/483/hahnemann-laboratories-inc-dba-alpine-pharmaceuticals/d1a1462c-573d-4053-bd5f-d58d8ce522bf)

## Related Officers

- [Drug Enforcement Administration](https://www.globalkeysolutions.net/people/john-a-gonzalez/51074472-cb23-4b72-8ca7-2d973670063e)

Company: https://www.globalkeysolutions.net/companies/hahnemann-laboratories-inc-dba-alpine-pharmaceuticals/449cf2ad-b13b-4c49-ae83-2f8fac91ae20

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df