FDA 483 - Shertech Pharmacy - July 02, 2019

An FDA inspection revealed significant deficiencies at a facility producing sterile injectable radiological drug products, specifically Mertiadiate-Tc99m LEU.

Key violations include: - **Aseptic Processing:** Personnel used non-sterile gloves during sterile drug product preparation. - **Cleanroom Maintenance:** Sporicidal agents were not used in cleanrooms or ISO 5 aseptic processing areas; only non-sterile disinfectants were used. - **Facility Design & Air Quality:** ISO-3 LAFH hoods were located within an ISO-8 Pharmacy Area without demonstrated prevention of poor-quality air influx (no smoke studies). Hoods were shut off overnight and only wiped with non-sterile solutions. Differential pressure between classified areas was not monitored. The ISO-8 Pharmacy Area had potential particulate sources (refrigerator, fan, non-HEPA AC vents, cluttered hoods). - **Environmental Monitoring:** No environmental monitoring procedures or documentation existed, and no EM was conducted during sterile processing. - **Aseptic Process Validation:** Media fills were not conducted to simulate worst-case aseptic production. - **Sterility Testing:** Finished sterile drug products, like Mertiadiate-Tc99m LEU, were not tested for sterility. - **Production & Process Controls:** No written procedures for production and process controls to assure drug product identity, strength, quality, and purity. Specifically, the firm used unweighed, unverified (b)(4) from an unknown supplier