FDA 483 - Abrams Royal Pharmacy - December 20, 2013

The FDA Form 483 details multiple deficiencies at a facility manufacturing sterile human drug products.

**Facility and Operations:** The firm operates a clean room (ISO 7) with laminar flow hoods (ISO 5) and an anteroom (ISO 8). Products like Glutathione MDV, Methionin/Choline Blend, Calcium Edetate, and Glycyrrhizic Acid are sterilized.

**Violations and Observations:** * **Aseptic Technique:** Technicians exhibited poor aseptic techniques, including touching sterile surfaces with non-sterile gloves, picking items off the floor, exposed skin at wrists, improper mouth/nose cover, torn gowns, and re-entering the clean room without changing gloves/gowns. Non-sterile gown clothing was also used. * **Sterility Testing & Release:** Drug products purporting to be sterile are not consistently tested for sterility and pyrogen-free requirements before release. Examples show products shipped before sterility results were received. In-use filters for sterilization were not tested. * **Environmental Control & Design:** The clean room and anteroom lack suitable construction for aseptic operations, including inadequate air pressure differential and cascade. Smoke studies to verify unidirectional airflow in ISO 5 hoods and rooms are not performed. The anteroom lacks air supply ducts and is separated by plastic strips, not a continuous barrier. * **Quality Control Unit Authority:** The QC unit fails to fully investigate sterility failures (6 of 1