DPT Laboratories, Ltd.
Overview
DPT Laboratories, Ltd. is a contract development and manufacturing organization specializing in semi-solid and liquid dosage forms. The company offers comprehensive services from pharmaceutical development to commercial manufacturing. As a subsidiary of the CMIC Group, DPT serves clients across various therapeutic areas, leveraging decades of industry expertise.
Core services & business areas
Therapeutic areas
API / Drug Master Files
DPT Laboratories, Ltd. holds 0 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.Inactive1968-09-04
FDA compliance signals
15 FDA enforcement records linked to this company.
- 4832026-02-10
Control procedures to monitor and validate performance
- 4832026-02-10
Absence of Written Procedures
- 4832018-12-14
Authority lacking to review records, investigate errors
- 4832018-12-14
Written records kept in individual logs
- 4832018-12-14
Identification of Equipment and Lines
- 4832016-08-26
SOPs not followed / documented
- 4832016-08-26
Procedures to be written and followed
- 4832016-08-26
Cleaning / Sanitizing / Maintenance
- 4832014-04-25
Label storage access limited to authorized personnel
- 4832014-04-25
Scientifically sound laboratory controls
- 4832014-04-25
Written procedures describing in detail
- 4832014-04-25
Written procedures not followed
- 4832014-04-25
Complete test data included in records
- 4832014-04-25
Protective Apparel Not Worn
- 4832014-04-25
No written record of investigation
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