# 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/d62df77c-3e9d-4646-afd0-17c80f817623

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

---

## Details

- Record Type: 483
- Company Name: Revive Rx LLC dba Revive Rx Pharmacy
- Inspection Date: 2022-05-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Revive Rx LLC dba Revive Rx Pharmacy in Houston, TX, revealed significant deficiencies in aseptic processing, cleanroom environment control, and equipment validation. Observations included poor aseptic techniques, inadequate sterile filtration, insufficient HEPA filter coverage, and improper cleanroom design and maintenance. These issues indicate a serious lack of control over sterile drug product manufacturing, leading to the disposal of multiple drug lots.

## Related Documents

- [483 - 2021-08-06](https://www.keypedia.com/records/483/revive-rx-llc-dba-revive-rx-pharmacy/b71db01e-8fd5-4bbe-ba98-e9b601e91269)
- [483 - 2022-05-04](https://www.keypedia.com/records/483/revive-rx-llc-dba-revive-rx-pharmacy/bb06d0e8-f0b5-43d6-886b-0b17e9425dd3)
- [UNTITLED_LETTER - 2023-06-30](https://www.keypedia.com/records/untitled_letter/revive-rx-llc-dba-revive-rx-pharmacy/6f831744-0c44-4700-8543-503a45e9aeaf)
- [483 - 2025-02-07](https://www.keypedia.com/records/483/revive-rx-llc-dba-revive-rx-pharmacy/8c14d757-1587-4a97-adf0-66ee7be7d31a)
- [WARNING_LETTER - 2025-02-07](https://www.keypedia.com/records/warning_letter/revive-rx-llc-dba-revive-rx-pharmacy/95af4bc5-dbe9-4cf0-9f12-326c692062d0)

## Related Officers

- [Cameron E. Moore](https://www.keypedia.com/people/cameron-e-moore/5a879539-24b7-4c54-99e4-b8e31f18ec9b)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab