FDA-Inspected Site

Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals

6 FDA inspections are on record for Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals in San Rafael, United States.

483· Form 483 issued

San Rafael, United States · Last updated July 9, 2026

Overview

  • 6 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-01-31.

At a glance

Inspections

6

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 Jan 2025 – 31 Jan 2025Human Drugs483On file
15 Jan 2020 – 28 Jan 2020Human Drugs483View 483 →
24 Apr 2017 – 27 Apr 2017Human Drugs483On file
25 Mar 2011Not recordedClean
10 Apr 2007Not recordedClean
11 Aug 2003Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

28 Jan 2020
21 CFR 211.165(e)

Test methods

Cited by Jolanna A Norton

28 Jan 2020
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jolanna A Norton

28 Jan 2020
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Jolanna A Norton

28 Jan 2020
21 CFR 211.84(d)(2)

Establish reliability of supplier's C of A

Cited by Jolanna A Norton

28 Jan 2020
21 CFR 211.84(e)

Rejecting When Specifications Not Met

Cited by Jolanna A Norton

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.84(e)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind this site's 3 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat