Osmotica Pharmaceutical US LLC
Form 483 issued May 2, 2025 · Marietta, Georgia
- Investigators
- Andrew O. Ejiofor· Samantha E. Cleek· Tomika Crafter
- Observations
- 2
- Pages
- 18
- FEI number
- 3009078927
In short: On May 2, 2025, FDA issued a Form 483 with 2 observations to Osmotica Pharmaceutical US LLC in Marietta, Georgia (FEI 3009078927). The investigators were Andrew O. Ejiofor, Samantha E. Cleek and Tomika Crafter. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.64 (investigator reports).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.64 (1×) · 312.60 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to report serious adverse events…
- 02
An investigation was not conducted in accordance…
This inspection in context
Andrew O. Ejiofor
5 documents · 2024–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Georgia.
The firmOsmotica Pharmaceutical US LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 312.64
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Osmotica Pharmaceutical US LLC?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.64 (investigator reports). The opening words of each observation are shown on this page.
Who inspected Osmotica Pharmaceutical US LLC?
Andrew O. Ejiofor, Samantha E. Cleek and Tomika Crafter are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Osmotica Pharmaceutical US LLC inspected by FDA?
This Form 483 is dated May 2, 2025.
How do I get the full Form 483 for Osmotica Pharmaceutical US LLC?
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.