Overview
- 30 FDA inspections are on record.
- 22 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-20.
At a glance
Inspections
30
Form 483s
22
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Oct 2025 – 20 Oct 2025 | Human Drugs | WL | View 483 → |
| 28 May 2025 – 5 Jun 2025 | Biologics | 483 | View 483 → |
| 5 Apr 2023 – 14 Apr 2023 | Human Drugs | 483 | View 483 → |
| 13 Oct 2021 – 22 Oct 2021 | Biologics | 483 | On file |
| 13 Oct 2021 – 22 Oct 2021 | Biologics | 483 | On file |
| 14 Jul 2021 – 20 Jul 2021 | Human Drugs | 483 | On file |
| 8 Apr 2019 – 15 Apr 2019 | Human Drugs | 483 | View 483 → |
| 31 Jul 2018 – 9 Aug 2018 | Biologics | 483 | On file |
| 15 Feb 2017 – 13 Mar 2017 | Human Drugs | 483 | View 483 → |
| 22 Aug 2016 – 26 Aug 2016 | Human Drugs | 483 | On file |
| 23 Sep 2015 – 28 Sep 2015 | Human Drugs | Clean | |
| 27 Aug 2015 – 10 Sep 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Oct 2025
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Joohi Castelvetere, Nicholas J Presto, Jacob G Lutz, Ramia Brzenjy, Shannon L Maisano
20 Oct 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Joohi Castelvetere, Nicholas J Presto, Jacob G Lutz, Ramia Brzenjy, Shannon L Maisano
20 Oct 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Joohi Castelvetere, Nicholas J Presto, Jacob G Lutz, Ramia Brzenjy, Shannon L Maisano
20 Oct 2025
21 CFR 211.63
Equipment Design, Size and Location
Cited by Joohi Castelvetere, Nicholas J Presto, Jacob G Lutz, Ramia Brzenjy, Shannon L Maisano
5 Jun 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Lewis K Antwi, Richard L Bartlett
Investigators
FDA investigators tied to this site in the record.
Rebecca E Dombrowski7 insp.
Emily J Orban5 insp.
Jeffrey D Meng4 insp.
Michele L Forster3 insp.
Joohi Castelvetere2 insp.
Jacob G Lutz2 insp.
Joseph A Piechocki2 insp.
Susan M Jackson2 insp.
Lauren M Lilly2 insp.
Sarah E Rhoades2 insp.
Sarah M Meng2 insp.
Sarah M Napier2 insp.
Nicholas J Presto1 insp.
Ramia Brzenjy1 insp.
Shannon L Maisano1 insp.
Lewis K Antwi1 insp.
Richard L Bartlett1 insp.
Michael Shanks1 insp.
Lindsey J Brown1 insp.
Amy S Graf1 insp.
Shirshendu K Deb1 insp.
Joseph T Madak1 insp.
Omotunde O Osunsanmi1 insp.
Mihaly S Ligmond1 insp.
Bei Y He1 insp.
Emilie Kahn1 insp.
Jacqueline M Diaz Albert1 insp.
Deborah M Trout1 insp.
Anthony F Lorenzo1 insp.
Christian Lynch1 insp.
Sanket N Patel1 insp.
Prabhu P Raju1 insp.
Salwa K Poole1 insp.
Miah I Schneider1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.142(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.86 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Par Health USA, LLC's 22 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