Galentic Pharma (india) Pvt. Ltd.
Overview
Galentic Pharma (india) Pvt. Ltd. is a pharmaceutical company headquartered in Chakala Midc, India, founded in 1992, with 201-500 employees.
FDA compliance signals
29 FDA enforcement records linked to this company.
- 4832022-12-08
Training--operations, GMPs, written procedures
- 4832022-12-08
Authority lacking to review records, investigate errors
- 4832022-12-08
Testing and release for distribution
- 4832022-12-08
Scientifically sound laboratory controls
- 4832022-12-08
Backup file not maintained
- 4832022-12-08
Validation lacking for sterile drug products
- 4832022-12-08
Procedures not in writing, fully followed
- 4832022-12-08
Written procedures not established/followed
- 4832022-12-08
Procedures for sterile drug products
- 4832022-12-08
Valid stability test methods
- 4832020-02-14
Procedures not in writing, fully followed
- 4832020-02-14
Investigations of discrepancies, failures
- 4832020-02-14
Identification of Persons Performing Significant Steps
- 4832020-02-14
Storage under appropriate conditions
- 4832020-02-14
Computer control of master formula records
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