Overview
- 8 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-10.
At a glance
Inspections
8
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Dec 2025 – 10 Dec 2025 | Human Drugs | 483 | View 483 → |
| 20 Feb 2024 – 23 Feb 2024 | Animal Drugs & Feeds | 483 | On file |
| 27 Dec 2022 – 10 Jan 2023 | Human Drugs | 483 | View 483 → |
| 19 Mar 2019 – 11 Apr 2019 | Human Drugs | Clean | |
| 26 Feb 2018 – 14 Mar 2018 | Human Drugs | 483 | View 483 → |
| 15 Aug 2016 – 19 Aug 2016 | Human Drugs | 483 | On file |
| 8 Apr 2014 – 17 Apr 2014 | Human Drugs | 483 | On file |
| 27 Feb 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Dec 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Paranthaman SenthamaraiKannan, Nelson N Ayangho
10 Dec 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Paranthaman SenthamaraiKannan, Nelson N Ayangho
10 Dec 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Paranthaman SenthamaraiKannan, Nelson N Ayangho
10 Dec 2025
21 CFR 211.68(b)
Computer control of master formula records
Cited by Paranthaman SenthamaraiKannan, Nelson N Ayangho
10 Jan 2023
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Rafeeq A Habeeb, Paranthaman SenthamaraiKannan
Investigators
FDA investigators tied to this site in the record.
Kathleen D Culver2 insp.
Nelson N Ayangho1 insp.
Logan T Williams1 insp.
Travis V Hull1 insp.
Rafeeq A Habeeb1 insp.
Michael P Sheehan1 insp.
Doan T Nguyen1 insp.
Matthew B Casale1 insp.
Laura Fontan1 insp.
Christian L Witkovskie1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | 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 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Piramal Pharma Solutions Inc.'s 7 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