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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