Overview
- 17 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-15.
At a glance
Inspections
17
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Nov 2024 – 15 Nov 2024 | Human Drugs | WL | On file |
| 6 Dec 2021 – 10 Dec 2021 | Human Drugs | Clean | |
| 15 Oct 2019 – 22 Oct 2019 | Human Drugs | Clean | |
| 14 Oct 2019 – 22 Oct 2019 | Human Drugs | Clean | |
| 10 Jun 2019 – 18 Jul 2019 | Human Drugs | WL | View 483 → |
| 18 Mar 2019 – 29 Mar 2019 | Human Drugs | 483 | View 483 → |
| 12 Dec 2018 – 19 Dec 2018 | Human Drugs | Clean | |
| 7 Sep 2018 – 11 Sep 2018 | Human Drugs | Clean | |
| 23 Oct 2017 – 27 Oct 2017 | Human Drugs | 483 | On file |
| 19 Sep 2017 – 28 Sep 2017 | Human Drugs | 483 | View 483 → |
| 6 Jun 2016 – 8 Jun 2016 | Human Drugs | Clean | |
| 17 Nov 2014 – 21 Nov 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Jul 2019
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Samantha J Bradley
Investigators
FDA investigators tied to this site in the record.
Seneca D Toms2 insp.
Adam R Cooke2 insp.
Cassandra L Abellard2 insp.
Khalid M Khan2 insp.
Samantha J Bradley2 insp.
Penny H Mccarver2 insp.
Jason F Chancey2 insp.
Santos E Camara1 insp.
Joan M Cantellops Figueroa1 insp.
Logan T Williams1 insp.
Megan T Ziegler1 insp.
Jason R Caballero1 insp.
Bonita S Chester1 insp.
Gideon N Esuzor1 insp.
Tracy R Ball1 insp.
Sonya M Edmonds1 insp.
Rachael A Moliver1 insp.
Noreen Muniz1 insp.
Brett D Weed1 insp.
Viviana Matta1 insp.
Jawaid Hamid1 insp.
Xiomara Copeland1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.42(c)(10)(iv) | 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(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | 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 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Exela Pharma Sciences, LLC.'s 8 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