Grandpa's Compounding Pharmacy, Inc. – FDA 483, Sep 10, 2013

The FDA Form 483 details significant deficiencies in aseptic processing and quality control at a facility manufacturing sterile injectable drugs.

**Facility and Operations:** The aseptic operations are conducted within an ISO-5 horizontal airflow hood, supported by an ISO-7 area and an ISO-8 ante-room.

**Violations and Observations:** * **Air Handling and Cleanroom Environment:** * Aseptic areas lack adequate HEPA-filtered air supply under positive pressure. * No raw data supports ISO-5 classification; the hood is labeled Class 7. * No records or qualification for the air handling system supplying ISO-7/8 areas. * The air supply duct's HEPA filter status is unknown, and it has unsecured sections with air leakage. * A small, unvalidated window-type air conditioner is used for circulation in the cleanroom, with unknown air source. * Air pressure monitoring is visual (plastic curtain movement) instead of measured. * No Non-Viable Particle (NVP) measurements are taken during dynamic operations. * No airflow pattern (smoke study) evaluations performed for ISO-5, ISO-7, or between ISO-7/8 areas. * **Personnel Gowning and Aseptic Practices:** * Personnel gowning (disposable smocks, covers) is non-sterile and not made of