Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-16.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Dec 2022 – 16 Dec 2022 | Human Drugs | 483 | View 483 → |
| 31 Jul 2018 – 6 Aug 2018 | Human Drugs | 483 | On file |
| 13 Jul 2015 – 23 Jul 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Dec 2022
FDCA 501(a)(2)(A)
Actionable microbial contamination, adjacent area
Cited by Sena G Dissmeyer, Brandy N Lepage, Karen A Briggs
16 Dec 2022
FDCA 501(a)(2)(A)
Beta-lactam drugs, inadequate sanitation
Cited by Sena G Dissmeyer, Brandy N Lepage, Karen A Briggs
16 Dec 2022
FDCA 501(a)(2)(A)
Cleanliness, ISO-classified areas
Cited by Sena G Dissmeyer, Brandy N Lepage, Karen A Briggs
16 Dec 2022
FDCA 501(a)(2)(A)
Disinfecting and cleaning agents, ISO 5 area
Cited by Sena G Dissmeyer, Brandy N Lepage, Karen A Briggs
16 Dec 2022
FDCA 501(a)(2)(A)
Disinfecting materials, aseptic processing area
Cited by Sena G Dissmeyer, Brandy N Lepage, Karen A Briggs
Investigators
FDA investigators tied to this site in the record.
Sena G Dissmeyer1 insp.
Brandy N Lepage1 insp.
Karen A Briggs1 insp.
Mindy M Chou1 insp.
Wilfred A Darang1 insp.
Nebil A Oumer1 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 |
| 21 CFR 211.113(b) | 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(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | 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 211.56(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 Form 483s
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