# FDA 483 - Hahnemann Laboratories, Inc.,  dba Alpine Pharmaceuticals - January 28, 2020

Source: https://www.globalkeysolutions.net/records/483/hahnemann-laboratories-inc-dba-alpine-pharmaceuticals/d1a1462c-573d-4053-bd5f-d58d8ce522bf

> FDA 483 for Hahnemann Laboratories, Inc.,  dba Alpine Pharmaceuticals on January 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hahnemann Laboratories, Inc.,  dba Alpine Pharmaceuticals
- Inspection Date: 2020-01-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals, a homeopathic drug manufacturer in San Rafael, CA, was inspected and cited for significant deficiencies across multiple quality systems. The inspection revealed failures in component rejection, supplier validation, test method validation, quality control unit procedures, and cGMP training for quality personnel. These issues indicate a systemic lack of adherence to good manufacturing practices.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b