Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals
Form 483 issued January 31, 2025 · San Rafael, California
- Observations
- 3
- Pages
- 3
- FEI number
- 3001239031
In short: On January 31, 2025, FDA issued a Form 483 with 3 observations to Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals in San Rafael, California (FEI 3001239031). Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, sensitivity, specificity, and reproducibility of test methods have not…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Questions about this 483
What did FDA find at Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and materials. The opening words of each observation are shown on this page.
When was Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals inspected by FDA?
This Form 483 is dated January 31, 2025.
How do I get the full Form 483 for Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.