Misemer Pharmaceutical, Inc
Form 483 issued February 23, 2026 · Ripley, Mississippi
- Inspection
- Feb 17 – Feb 23, 2026
- Investigator
- Kellie R. Riggs
- Observations
- 4
- Pages
- 4
- FEI number
- 3016439754
In short: On February 23, 2026, FDA issued a Form 483 with 4 observations to Misemer Pharmaceutical, Inc in Ripley, Mississippi (FEI 3016439754) after an inspection that ran Feb 17 – Feb 23, 2026. The investigator was Kellie R. Riggs. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the…
- 02
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the…
- 03
An annual report was not submitted within 60 days of the anniversary date of U.S. approval…
- 04
Written procedures have not been developed for the reporting to FDA of post…
This inspection in context
Kellie R. Riggs
1 document · 2026
Cites 314.80(b) (postmarketing reporting of adverse drug experiences) more than any other section. Most of their documents are for sites in Mississippi.
The firmMisemer Pharmaceutical, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 314.80(c)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Misemer Pharmaceutical, Inc?
FDA listed 4 observations on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected Misemer Pharmaceutical, Inc?
Kellie R. Riggs is named on this Form 483, for the inspection of Feb 17 – Feb 23, 2026. Each investigator has a profile showing what they cite most.
When was Misemer Pharmaceutical, Inc inspected by FDA?
The inspection ran Feb 17 – Feb 23, 2026, and the Form 483 is dated February 23, 2026.
How do I get the full Form 483 for Misemer Pharmaceutical, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.