Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-09-27.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Sep 2022 | Foods & Cosmetics | Clean | |
| 28 Dec 2016 | Human Drugs | Clean | |
| 5 Apr 2016 – 5 May 2016 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Written procedures describing in detail
Cited by Michael D Thatcher, Javonica F Penn, Ucheabuchi C Chudi-Nwankwor, Denise R Pinkerton
Written procedures describing in detail
Cited by Michael D Thatcher, Javonica F Penn, Ucheabuchi C Chudi-Nwankwor, Denise R Pinkerton
Written procedures describing in detail
Cited by Michael D Thatcher, Javonica F Penn, Ucheabuchi C Chudi-Nwankwor, Denise R Pinkerton
Procedures are written, and followed
Cited by Michael D Thatcher, Javonica F Penn, Ucheabuchi C Chudi-Nwankwor, Denise R Pinkerton
Procedures are written, and followed
Cited by Michael D Thatcher, Javonica F Penn, Ucheabuchi C Chudi-Nwankwor, Denise R Pinkerton
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 211.122(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.132(b)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.134(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.150 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 4x |
Full site report
Get the verbatim findings behind Profarma Distribution LLC's 1 Form 483
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