Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals
FDA inspection history in San Rafael, California, 2020 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at San Rafael, California.
- 2020The longest 483 on file: 5 observations over 7 pages at San Rafael, California.
- 2025One Form 483, at San Rafael, California.
Cited most
Across all Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals observations on file
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 2101
- 21 CFR 211.160General requirements1
- 21 CFR 211.165(e)Testing and release for distribution1
The complete Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
San Rafael, California
Two Form 483s · 2020 to 2025 · 5 observations
Latest: Form 483, Jan 31, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-31 | 483 Form 483 | San Rafael, California | — | $99 |
| 2020-01-28 | 483 Form 483 | San Rafael, California | 5 | $99 |
Investigators on these documents
FEI number 3001239031 · most recent document Jan 31, 2025
About Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals
How many FDA Form 483s has Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals received?
FDA Intel has 2 Form 483s on file for Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals; the most recent is dated Jan 31, 2025.
When was Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals last inspected by FDA?
The most recent FDA inspection document on file for Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals is a Form 483 dated Jan 31, 2025, for the site in San Rafael, California.
What did FDA cite at Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals?
The regulations cited most in the observations on file for Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals are 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 210, 1 time.