Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-02-25.
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 |
|---|---|---|---|
| 22 Feb 2022 – 25 Feb 2022 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Feb 2022
21 CFR 211.186(b)(4)
Weight or measure of each component
Cited by Joanne E King, Lillian M Colon-Mcknight
25 Feb 2022
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Joanne E King, Lillian M Colon-Mcknight
25 Feb 2022
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Joanne E King, Lillian M Colon-Mcknight
25 Feb 2022
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Joanne E King, Lillian M Colon-Mcknight
25 Feb 2022
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by Joanne E King, Lillian M Colon-Mcknight
Investigators
FDA investigators tied to this site in the record.
Joanne E King1 insp.
Lillian M Colon-Mcknight1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.186(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | 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 MOHNARK PHARMACEUTICALS INC.'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