Overview
- 12 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-15.
At a glance
Inspections
12
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 May 2026 – 15 May 2026 | Human Drugs | 483 | View 483 → |
| 27 Aug 2024 – 6 Sep 2024 | Human Drugs | 483 | View 483 → |
| 4 Oct 2021 – 15 Oct 2021 | Human Drugs | 483 | View 483 → |
| 7 Jan 2020 – 10 Jan 2020 | Human Drugs | Clean | |
| 13 May 2019 – 22 May 2019 | Human Drugs | 483 | View 483 → |
| 11 Dec 2018 – 21 Dec 2018 | Human Drugs | 483 | View 483 → |
| 23 Feb 2017 – 1 Mar 2017 | Human Drugs | 483 | View 483 → |
| 26 May 2015 – 1 Jun 2015 | Human Drugs | Clean | |
| 15 Jun 2012 | Not recorded | Clean | |
| 23 Nov 2010 | Not recorded | 483 | View 483 → |
| 19 Jan 2010 | Not recorded | 483 | View 483 → |
| 30 Aug 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 May 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Syeda N Mahazabin, Divek R Jumani, Young K Chou
15 May 2026
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Syeda N Mahazabin, Divek R Jumani, Young K Chou
15 May 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Syeda N Mahazabin, Divek R Jumani, Young K Chou
15 May 2026
21 CFR 211.165(b)
Microbiological testing
Cited by Syeda N Mahazabin, Divek R Jumani, Young K Chou
15 May 2026
21 CFR 211.165(d)
Acceptance criteria for sampling & testing
Cited by Syeda N Mahazabin, Divek R Jumani, Young K Chou
Investigators
FDA investigators tied to this site in the record.
Karen L Kosar3 insp.
Syeda N Mahazabin2 insp.
Johnna L Bleem2 insp.
Divek R Jumani1 insp.
Young K Chou1 insp.
Mindy M Chou1 insp.
Lauren H Augustyniak1 insp.
William J Leonard1 insp.
Niketa Patel1 insp.
Yvesna C Blaise1 insp.
Parul M Patel1 insp.
Harry J Brewer1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Unither Manufacturing LLC.'s 8 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