MOHNARK PHARMACEUTICALS INC.
Form 483 issued February 25, 2022 · Fort Pierce, Florida
- Inspection
- Feb 22 – Feb 25, 2022
- Investigators
- Joanne E. King· Lillian M. Colon-Mcknight
- Observations
- 5
- Pages
- 5
- FEI number
- 3015500516
In short: On February 25, 2022, FDA issued a Form 483 with 5 observations to MOHNARK PHARMACEUTICALS INC. in Fort Pierce, Florida (FEI 3015500516) after an inspection that ran Feb 22 – Feb 25, 2022. The investigators were Joanne E. King and Lillian M. Colon-Mcknight. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
The master production and control records lack an accurate statement of the weight and measure of…
- 04
Equipment for adequate control over dust is not provided when appropriate for the manufacture, processing, packing…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmMOHNARK PHARMACEUTICALS INC. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MOHNARK PHARMACEUTICALS INC.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The opening words of each observation are shown on this page.
Who inspected MOHNARK PHARMACEUTICALS INC.?
Joanne E. King and Lillian M. Colon-Mcknight are named on this Form 483, for the inspection of Feb 22 – Feb 25, 2022. Each investigator has a profile showing what they cite most.
When was MOHNARK PHARMACEUTICALS INC. inspected by FDA?
The inspection ran Feb 22 – Feb 25, 2022, and the Form 483 is dated February 25, 2022.
How do I get the full Form 483 for MOHNARK PHARMACEUTICALS INC.?
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