Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-11.
At a glance
Inspections
6
Form 483s
6
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2023 – 11 Apr 2023 | Foods & Cosmetics | 483 | View 483 → |
| 25 Jan 2022 – 15 Feb 2022 | Foods & Cosmetics | 483 | View 483 → |
| 20 Aug 2018 – 22 Aug 2018 | Foods & Cosmetics | 483 | View 483 → |
| 11 Aug 2015 – 11 Sep 2015 | Human Drugs | 483 | View 483 → |
| 10 Feb 2014 – 19 Feb 2014 | Human Drugs | WL | On file |
| 29 Jan 2013 – 22 Feb 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Apr 2023
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Heather A Mccauley, Matt D Suedkamp
11 Apr 2023
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Heather A Mccauley, Matt D Suedkamp
11 Apr 2023
21 CFR 111.70(b)(3)
Specifications - contamination limits
Cited by Heather A Mccauley, Matt D Suedkamp
11 Apr 2023
21 CFR 111.70(b)(3)
Specifications - contamination limits
Cited by Heather A Mccauley, Matt D Suedkamp
11 Apr 2023
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Heather A Mccauley, Matt D Suedkamp
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 111.70(e) | Cited across public-safe Form 483 observations | 12x |
| 21 CFR 111.120(c) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.15(d)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.27(a)(3)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 589.2000(d)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.260(l)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.325(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind PI Pharma Inc'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