FDA 483 - Revive Rx LLC dba Revive Rx Pharmacy - May 04, 2022

An FDA Form 483 was issued following an inspection, identifying multiple deficiencies in aseptic processing and facility controls.

Observations included personnel blocking first-pass air during aseptic manipulations. Specifically, on April 26, 2022, a pharmacy technician was observed reaching over open vials of "(b)(4) Sterile Solution for Injection, Lot #(b)(4)," leading to the disposal of the lot. On April 19, 2022, a technician used poor aseptic techniques when connecting a syringe to tubing for "(b)(4) Lot #(b)(4)," and both the PIC and technician failed to disinfect sterile gloves before returning components to the ISO 5 BSC, resulting in the disposal of this lot as well.

The firm failed to use sterile pharmaceutical-grade (b)(4) during sterile drug product processing, instead using a (b)(4) for "Dexamethasone 24 mg/ml Sterile Solution pH 7." Two lots, #585669 and #668512, remain within expiry with six patient prescriptions dispensed.

Inadequate HEPA filter coverage and airflow were noted, with the (b)(4) Systems lacking sufficient HEPA filters to maintain an ISO 5 environment from the BSC to the (b)(4) and crimping station, a repeat observation. (b)(4) integrity testing for the Sterile (b)(4) was not adequately performed or recorded. On