Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals
Form 483 issued January 28, 2020 · San Rafael, California
- Inspection
- Jan 28, 2020
- Investigator
- Jolanna A. Norton
- Observations
- 5
- Pages
- 7
- FEI number
- 3001239031
In short: On January 28, 2020, FDA issued a Form 483 with 5 observations to Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals in San Rafael, California (FEI 3001239031) after an inspection that ran Jan 28, 2020. The investigator was Jolanna A. Norton. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 02
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 03
The accuracy, sensitivity and reproducibility of test methods have not…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Jolanna A. Norton
22 documents · 2017–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmHahnemann Laboratories, Inc. dba Alpine Pharmaceuticals history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals?
FDA listed 5 observations on this Form 483, mostly about materials, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals?
Jolanna A. Norton is named on this Form 483, for the inspection of Jan 28, 2020. Each investigator has a profile showing what they cite most.
When was Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals inspected by FDA?
The inspection ran Jan 28, 2020, and the Form 483 is dated January 28, 2020.
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.