Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-02-28.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Feb 2022 – 28 Feb 2022 | Human Drugs | Clean | |
| 2 Dec 2019 – 13 Dec 2019 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Dec 2019
FDCA 501(a)(2)(A)
Actionable microbial contamination, adjacent area
Cited by Christopher R Czajka, Marcus F Yambot
13 Dec 2019
FDCA 501(a)(2)(A)
Actionable microbial contamination, ISO 5 area
Cited by Christopher R Czajka, Marcus F Yambot
13 Dec 2019
FDCA 501(a)(2)(A)
Air flow quality, higher classified area
Cited by Christopher R Czajka, Marcus F Yambot
13 Dec 2019
FDCA 501(a)(2)(A)
Disinfecting and cleaning agents, ISO 5 area
Cited by Christopher R Czajka, Marcus F Yambot
13 Dec 2019
FDCA 501(a)(2)(A)
Dust-collecting overhangs, surrounding area of ISO 5
Cited by Christopher R Czajka, Marcus F Yambot
Investigators
FDA investigators tied to this site in the record.
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 this site's 1 Form 483
Source PDFs 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