Osmotica Pharmaceutical US LLC
FDA inspection history in Marietta, Georgia, 2019 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Marietta, Georgia.
- 2025One Form 483, at Marietta, Georgia.
- 2025The longest 483 on file: 2 observations over 18 pages at Marietta, Georgia.
Cited most
Across all Osmotica Pharmaceutical US observations on file
- 21 CFR 211.25(a)Personnel qualifications1
- 21 CFR 312.60General responsibilities of investigators1
- 21 CFR 312.64Investigator reports1
The complete Osmotica Pharmaceutical US file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Marietta, Georgia
Two Form 483s · 2019 to 2025 · 3 observations
Latest: Form 483, May 2, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-02 | 483 Form 483 | Marietta, Georgia | 2 | $99 |
| 2019-01-18 | 483 Form 483 | Marietta, Georgia | 1 | $99 |
Investigators on these documents
Andrew O. Ejiofor (1)Gideon N. Esuzor (1)Samantha E. Cleek (1)Tomika Crafter (1)
FEI number 3009078927 · most recent document May 2, 2025
About Osmotica Pharmaceutical US LLC
How many FDA Form 483s has Osmotica Pharmaceutical US LLC received?
FDA Intel has 2 Form 483s on file for Osmotica Pharmaceutical US LLC; the most recent is dated May 2, 2025.
When was Osmotica Pharmaceutical US LLC last inspected by FDA?
The most recent FDA inspection document on file for Osmotica Pharmaceutical US LLC is a Form 483 dated May 2, 2025, for the site in Marietta, Georgia.
What did FDA cite at Osmotica Pharmaceutical US LLC?
The regulations cited most in the observations on file for Osmotica Pharmaceutical US LLC are 21 CFR 211.25(a) (Personnel qualifications), 1 time; 21 CFR 312.60 (General responsibilities of investigators), 1 time; 21 CFR 312.64 (Investigator reports), 1 time.