Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
MPMOHNARK PHARMACEUTICALS INC.Davie, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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 |
Source document
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PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 5 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere