Overview
- 13 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-14.
At a glance
Inspections
13
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 May 2026 – 14 May 2026 | Human Drugs | 483 | View 483 → |
| 5 Mar 2024 – 11 Mar 2024 | Human Drugs | 483 | View 483 → |
| 21 Aug 2023 – 29 Aug 2023 | Human Drugs | 483 | View 483 → |
| 8 Aug 2022 – 19 Aug 2022 | Human Drugs | 483 | View 483 → |
| 22 Oct 2021 – 10 Nov 2021 | Human Drugs | Clean | |
| 20 Jul 2021 – 30 Jul 2021 | Human Drugs | 483 | View 483 → |
| 23 Mar 2020 – 27 Mar 2020 | Human Drugs | Clean | |
| 20 May 2019 – 28 May 2019 | Human Drugs | Clean | |
| 25 Oct 2018 – 6 Nov 2018 | Human Drugs | 483 | On file |
| 18 Jul 2017 | Human Drugs | Clean | |
| 22 Jun 2016 – 27 Jun 2016 | Human Drugs | Clean | |
| 5 Oct 2015 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
14 May 2026
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by James R Birkenstamm
14 May 2026
FDCA 582(b)(4)
Systems in place to comply with verification requirements
Cited by James R Birkenstamm
Investigators
FDA investigators tied to this site in the record.
James R Birkenstamm2 insp.
Frederick Razzaghi2 insp.
Tyanna N Hadley1 insp.
Alice S Tsao1 insp.
Ankur C Patel1 insp.
David A Oluwo1 insp.
Tanya R Syffrard1 insp.
Pushpa S Jayasekara1 insp.
Daniel J Min1 insp.
Rose L Jean-Mary1 insp.
Odera I Ekwunife1 insp.
Lata C Mathew1 insp.
Jogy George1 insp.
Adetutu M Gidado1 insp.
Nicholas A Violand1 insp.
Niketa Patel1 insp.
Barbara J Wilimczyk-Macri1 insp.
Paul L Bellamy1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 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 |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Appco Pharma LLC's 6 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