Overview
- 11 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-03.
At a glance
Inspections
11
Form 483s
10
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Mar 2026 – 3 Apr 2026 | Human Drugs | 483 | View 483 → |
| 23 Jun 2025 – 27 Jun 2025 | Human Drugs | 483 | View 483 → |
| 11 Dec 2023 – 15 Dec 2023 | Human Drugs | 483 | View 483 → |
| 31 Jul 2023 – 3 Aug 2023 | Human Drugs | Clean | |
| 18 Jul 2022 – 22 Jul 2022 | Human Drugs | 483 | View 483 → |
| 24 Jan 2022 – 28 Jan 2022 | Human Drugs | 483 | View 483 → |
| 21 Jun 2021 – 25 Jun 2021 | Human Drugs | 483 | View 483 → |
| 13 Jan 2020 – 17 Jan 2020 | Human Drugs | 483 | View 483 → |
| 7 Aug 2019 – 21 Aug 2019 | Human Drugs | 483 | On file |
| 22 Oct 2018 – 26 Oct 2018 | Human Drugs | 483 | View 483 → |
| 4 Dec 2017 – 8 Dec 2017 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Apr 2026
21 CFR 211.188
Prepared for each batch, include complete information
Cited by David A Oluwo, Ofuje D Daniyan
3 Apr 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by David A Oluwo, Ofuje D Daniyan
3 Apr 2026
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by David A Oluwo, Ofuje D Daniyan
27 Jun 2025
21 CFR 211.68(b)
Computer control of master formula records
Cited by David A Oluwo, Kara J Wright
Investigators
FDA investigators tied to this site in the record.
David A Oluwo2 insp.
Tekalign Wondimu2 insp.
William J Leonard2 insp.
Sena G Dissmeyer2 insp.
Craig D Zagata2 insp.
Ofuje D Daniyan1 insp.
Kara J Wright1 insp.
Yaharn Su1 insp.
Johnny D Nwankwo1 insp.
Azeezat M Lawal1 insp.
Joseph L Despins1 insp.
Roseline N Boateng1 insp.
Karen A Briggs1 insp.
Marcus A Ray1 insp.
Zhao Wang1 insp.
Zhong Li1 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 | 6x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | 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 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Granules Pharmaceuticals Inc.'s 10 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