Osmotica Pharmaceutical US LLC
Form 483 issued January 18, 2019 · Marietta, Georgia
- Inspection
- Jan 15 – Jan 18, 2019
- Investigator
- Gideon N. Esuzor
- Observations
- 1
- Pages
- 2
- FEI number
- 3009078927
In short: On January 18, 2019, FDA issued a Form 483 with 1 observation to Osmotica Pharmaceutical US LLC in Marietta, Georgia (FEI 3009078927) after an inspection that ran Jan 15 – Jan 18, 2019. The investigator was Gideon N. Esuzor. Most observations concern quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
GMP training is not conducted on a continuing basis to assure that employees remain familiar with…
This inspection in context
Gideon N. Esuzor
3 documents · 2019
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Osmotica Pharmaceutical US LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Osmotica Pharmaceutical US LLC?
Gideon N. Esuzor is named on this Form 483, for the inspection of Jan 15 – Jan 18, 2019. Each investigator has a profile showing what they cite most.
When was Osmotica Pharmaceutical US LLC inspected by FDA?
The inspection ran Jan 15 – Jan 18, 2019, and the Form 483 is dated January 18, 2019.
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.