Overview
- 12 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-26.
At a glance
Inspections
12
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jun 2025 – 26 Jun 2025 | Human Drugs | 483 | View 483 → |
| 9 Oct 2019 – 10 Oct 2019 | Human Drugs | Clean | |
| 6 Feb 2018 – 9 Feb 2018 | Human Drugs | 483 | View 483 → |
| 4 Nov 2014 – 5 Nov 2014 | Human Drugs | Clean | |
| 22 Oct 2013 – 29 Oct 2013 | Human Drugs | 483 | View 483 → |
| 13 Oct 2011 | Not recorded | Clean | |
| 30 Nov 2010 | Not recorded | 483 | View 483 → |
| 19 Jan 2010 | Not recorded | 483 | View 483 → |
| 10 Dec 2008 | Not recorded | 483 | View 483 → |
| 22 Jun 2007 | Not recorded | Clean | |
| 14 Dec 2004 | Not recorded | Clean | |
| 17 Sep 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jun 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Cecilia H Kieu, Aranjeet Singh
9 Feb 2018
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Andrew K Haack, Annette L Diggs, Anita Narula
9 Feb 2018
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Andrew K Haack, Annette L Diggs, Anita Narula
Investigators
FDA investigators tied to this site in the record.
Sunitha K Rajaram2 insp.
Cecilia H Kieu1 insp.
Aranjeet Singh1 insp.
Farhana Khan1 insp.
Andrew K Haack1 insp.
Annette L Diggs1 insp.
Anita Narula1 insp.
Lawrence Y Lee1 insp.
Sangeeta M Khurana1 insp.
Nancy E Byerly1 insp.
Barbara J Breithaupt1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind HF Acquisition Co LLC's 6 Form 483s
Source PDFs, verbatim observations, 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