Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-14.
At a glance
Inspections
7
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Nov 2025 – 14 Nov 2025 | Human Drugs | 483 | On file |
| 5 Aug 2024 – 30 Sep 2024 | Human Drugs | 483 | View 483 → |
| 6 Sep 2023 – 19 Sep 2023 | Human Drugs | 483 | View 483 → |
| 3 May 2021 – 14 May 2021 | Human Drugs | 483 | View 483 → |
| 11 Apr 2018 – 26 Apr 2018 | Human Drugs | 483 | View 483 → |
| 5 Oct 2015 – 9 Oct 2015 | Human Drugs | WL | On file |
| 13 Oct 2014 – 17 Oct 2014 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Absence of Written Procedures
Cited by Ucheabuchi C Chudi-Nwankwor, Simone E Pitts, Jazmine N Brown, Lauren H Augustyniak
Actual vs. theoretical yields not determined
Cited by Ucheabuchi C Chudi-Nwankwor, Simone E Pitts, Jazmine N Brown, Lauren H Augustyniak
Written in-process control procedures
Cited by Ucheabuchi C Chudi-Nwankwor, Simone E Pitts, Jazmine N Brown, Lauren H Augustyniak
Procedures for sterile drug products
Cited by Ucheabuchi C Chudi-Nwankwor, Simone E Pitts, Jazmine N Brown, Lauren H Augustyniak
Investigations of discrepancies, failures
Cited by Ucheabuchi C Chudi-Nwankwor, Simone E Pitts, Jazmine N Brown, Lauren H Augustyniak
Investigators
FDA investigators tied to this site in the record.
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 | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | 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)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(b)(2)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pine Pharmaceuticals, 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