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

Source: https://www.keypedia.com/records/483/revive-rx-llc-dba-revive-rx-pharmacy/bb06d0e8-f0b5-43d6-886b-0b17e9425dd3

> FDA 483 for Revive Rx LLC dba Revive Rx Pharmacy on May 04, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Revive Rx LLC dba Revive Rx Pharmacy
- Inspection Date: 2022-05-04
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: 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

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Company: https://www.keypedia.com/companies/revive-rx-llc-dba-revive-rx-pharmacy/76ca0e11-cf06-411e-a944-bb16f40464d4

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9