Overview
- 19 FDA inspections are on record.
- 15 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-12.
At a glance
Inspections
19
Form 483s
15
EIRs
8
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Apr 2025 – 12 May 2025 | Human Drugs | 483 | View 483 → |
| 18 Jul 2023 – 2 Aug 2023 | Human Drugs | 483 | On file |
| 13 Apr 2022 – 22 Apr 2022 | Human Drugs | WL | View 483 → |
| 24 Aug 2021 – 1 Sep 2021 | Human Drugs | 483 | View 483 → |
| 4 Dec 2019 – 12 Dec 2019 | Human Drugs | 483 | View 483 → |
| 11 Dec 2018 – 19 Dec 2018 | Human Drugs | 483 | View 483 → |
| 8 Jan 2018 – 12 Jan 2018 | Human Drugs | 483 | View 483 → |
| 7 Nov 2016 – 10 Nov 2016 | Human Drugs | 483 | View 483 → |
| 5 Jan 2016 – 8 Jan 2016 | Human Drugs | 483 | View 483 → |
| 17 Aug 2015 – 21 Aug 2015 | Human Drugs | 483 | View 483 → |
| 11 Jun 2013 – 21 Jun 2013 | Human Drugs | 483 | On file |
| 2 Feb 2012 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 May 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Margaret M Annes, Milton J De Jesus Tavarez, Stephon D Tillis, Jeffrey T Prosterman
12 May 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Margaret M Annes, Milton J De Jesus Tavarez, Stephon D Tillis, Jeffrey T Prosterman
12 May 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Margaret M Annes, Milton J De Jesus Tavarez, Stephon D Tillis, Jeffrey T Prosterman
12 May 2025
21 CFR 211.84(d)(2)
Component written specification
Cited by Margaret M Annes, Milton J De Jesus Tavarez, Stephon D Tillis, Jeffrey T Prosterman
22 Apr 2022
21 CFR 211.100(a)
Approval and review of procedures
Cited by Patty P Kaewussdangkul, Adaris Mas Rivera, Martrice A Packer
Investigators
FDA investigators tied to this site in the record.
Patty P Kaewussdangkul5 insp.
Scott T Ballard4 insp.
Margaret M Annes2 insp.
Milton J De Jesus Tavarez1 insp.
Stephon D Tillis1 insp.
Jeffrey T Prosterman1 insp.
Christopher N Tran1 insp.
Rodney L Tinzie1 insp.
Oluwasefunm Agbanigo1 insp.
Adaris Mas Rivera1 insp.
Martrice A Packer1 insp.
Saleem A Akhtar1 insp.
Shelby N Marler1 insp.
Unnee Ranjan1 insp.
Matthew R Maddox1 insp.
Lucas B Leake1 insp.
Stephen D Brown1 insp.
Adrian Rodriguez1 insp.
Roy Baby1 insp.
Karen C Daugherty1 insp.
David M Beltran1 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 | 11x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sovereign Pharmaceuticals, LLC's 15 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