Osmotica Pharmaceutical US LLC — FDA Facility Profile
Osmotica Pharmaceutical US LLC is an FDA-registered facility (FEI 3009078927) located in Marietta, GA, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 2, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (3 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 3, latest Feb 28, 2018
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 2, 2025 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Training--operations, GMPs, written procedures (21 CFR 211.25(a)) SOPs not followed / documented (21 CFR 211.100(b)) Absence of Written Procedures (21 CFR 211.100(a)) and 2 more |
| Aug 7, 2019 | No Action Indicated (NAI) | No citations listed |
| Jan 18, 2019 | Voluntary Action Indicated (VAI) | GMP Training Frequency (21 CFR 211.25(a)) |
| Nov 12, 2015 | No Action Indicated (NAI) | No citations listed |
| Apr 26, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Feb 28, 2018 | Class III | D-0581-2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx… Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER… |
| Dec 18, 2017 | Class III | D-0110-2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx… and 1 more product Subpotent Drug |
| Sep 16, 2013 | Class III | D-1067-2013 | Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a)… Failed Dissolution Specification:12 hour time point at 18 months of product shelf life. |
Facility details
- Company
- Osmotica Pharmaceutical US LLC
- Location
- Marietta, GA (US)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs