Invagen Pharmaceuticals, Inc.
Overview
Invagen Pharmaceuticals, Inc. is a leading pharmaceutical company that focuses on the development, manufacture, and distribution of generic medicines. As a subsidiary of the global pharmaceutical company Cipla Limited, Invagen is committed to providing affordable healthcare solutions worldwide.
FDA compliance signals
25 FDA enforcement records linked to this company.
- recall — Class I2024-01-17
Defective Container: powder may leak out of the pouch
- recall — Class III2020-05-27
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
- 4832019-12-06
Testing and release for distribution
- 4832019-12-06
Written in-process control procedures
- 4832019-12-06
Batch production and Batch Control Record Requirements
- recall — Class III2019-07-10
Defective Container; actuator may improperly function and affect dose delivery.
- recall — Class II2019-04-24
Presence of Particulate Matter.
- recall — Class II2019-04-24
Presence of Particulate Matter.
- recall — Class II2019-04-24
Presence of Particulate Matter.
- recall — Class III2018-10-17
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
- recall — Class III2018-09-26
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
- 4832018-05-25
Mix-up
- 4832018-05-25
Backup file not maintained
- 4832018-05-25
Scientifically sound laboratory controls
- 4832018-05-25
Written program not followed
Related companies
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.