Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-03-22.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2019 – 22 Mar 2019 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Mar 2019
FDCA 501(a)(2)(A)
Air flow quality, higher classified area
Cited by Adam R Cooke, Rachael L Cook
22 Mar 2019
FDCA 501(a)(2)(A)
Disinfecting materials, aseptic processing area
Cited by Adam R Cooke, Rachael L Cook
22 Mar 2019
FDCA 501(a)(2)(A)
Exposure of personnel in aspectic processing
Cited by Adam R Cooke, Rachael L Cook
Investigators
FDA investigators tied to this site in the record.
Adam R Cooke1 insp.
Rachael L Cook1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 8x |
Full site report
Get the verbatim findings behind CMC Enterprise Pharmacy's 1 Form 483
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