Pharmaceutics International, Inc.
Overview
Pharmaceutics International, Inc. (Pii) is a leading contract development and manufacturing organization (CDMO) that specializes in providing end-to-end drug development and manufacturing services. Pii caters to the pharmaceutical and biotech industries by offering solutions that range from early-stage dose form development to commercial scale production.
Therapeutic areas
FDA compliance signals
13 FDA enforcement records linked to this company.
- 4832026-03-06
Investigations of discrepancies, failures
- 4832026-03-06
Absence of Written Procedures
- 4832026-03-06
Prepared for each batch, include complete information
- 4832026-03-06
Procedures for sterile drug products
- 4832026-03-06
Sanitation--buildings not clean, free of infestation
- 4832026-03-06
Cleaning System
- 4832026-03-06
Written procedures not established/followed
- 4832026-03-06
Validation lacking for sterile drug products
- 4832026-03-06
Deviations from laboratory control requirements
- 4832024-12-06
Reports of Analysis (Components)
- 4832024-12-06
Equipment Design, Size and Location
- 4832024-12-06
Cleaning SOPs/instructions
- 4832024-12-06
Establishment of calibration procedures
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