FDA 483 - AnazaoHealth Corporation - December 23, 2009

An FDA inspection of AnazaoHealth Corporation, a pharmacy in Tampa, FL, conducted from December 1-23, 2009, revealed significant deviations from current Good Manufacturing Practices (cGMP). The findings, documented in a Form FDA 483, highlighted critical deficiencies primarily within the Nuclear Pharmacy.

Key violations included the absence of a dedicated Quality Control Unit and a severe lack of environmental controls crucial for aseptic processing. Inspectors observed non-sterile items introduced into ISO5 hoods, inadequate personnel gowning and aseptic techniques, and risks of cross-contamination due to improper material and personnel movement between controlled areas. Facility surfaces were not easily cleanable, and differential pressure monitoring was insufficient.

Further systemic issues encompassed inadequate media fill procedures, incomplete sterility and endotoxin testing, and a failure to investigate out-of-specification results or environmental monitoring excursions. Documentation practices were poor, with inconsistent lot numbering, missing compounding records, and the use of expired chemicals. The firm lacked a robust stability testing program to support expiration dating, and its complaint handling procedures were found to be inadequate.

AnazaoHealth Corporation is obligated to implement comprehensive corrective and preventive actions to address these observations, ensuring product quality, patient safety, and full compliance with FDA regulatory standards for drug manufacturing.