Osmotica Pharmaceutical Corp.
Overview
Osmotica Pharmaceutical Corp. is a pharmaceutical company headquartered in Bridgewater, United States, founded in 2000, with 201-500 employees.
FDA compliance signals
11 FDA enforcement records linked to this company.
- 4832025-05-02
Training--operations, GMPs, written procedures
- 4832025-05-02
SOPs not followed / documented
- 4832025-05-02
Written procedures fail to include
- 4832025-05-02
Absence of Written Procedures
- 4832025-05-02
Complaint Handling Procedure
- 4832025-05-02
Procedures not in writing, fully followed
- 4832019-01-18
GMP Training Frequency
- recall — Class III2018-03-14
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
- recall — Class III2017-12-27
Subpotent Drug
- recall — Class III2017-12-27
Subpotent Drug
- recall — Class III2013-10-09
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
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