Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-21.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Apr 2023 – 21 Apr 2023 | Human Drugs | 483 | View 483 → |
| 16 Apr 2018 – 19 Apr 2018 | Human Drugs | 483 | View 483 → |
| 16 Dec 2015 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Apr 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Marvin D Jones, Martrice A Packer, Jessica M Simpson
21 Apr 2023
21 CFR 211.111
Establishment of time limitations
Cited by Marvin D Jones, Martrice A Packer, Jessica M Simpson
21 Apr 2023
21 CFR 211.115(a)
Reprocessing procedures lack steps to be taken
Cited by Marvin D Jones, Martrice A Packer, Jessica M Simpson
21 Apr 2023
21 CFR 211.137(a)
Expiration date lacking
Cited by Marvin D Jones, Martrice A Packer, Jessica M Simpson
21 Apr 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Marvin D Jones, Martrice A Packer, Jessica M Simpson
Investigators
FDA investigators tied to this site in the record.
Marvin D Jones1 insp.
Martrice A Packer1 insp.
Jessica M Simpson1 insp.
Jared P Stevens1 insp.
Joseph F Owens1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.196 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | 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 ABC Compounding Co., Inc.'s 2 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