# FDA 483 - Revive Rx LLC dba Revive Rx Pharmacy - February 07, 2025

Source: https://www.keypedia.com/records/483/revive-rx-llc-dba-revive-rx-pharmacy/8c14d757-1587-4a97-adf0-66ee7be7d31a

> FDA 483 for Revive Rx LLC dba Revive Rx Pharmacy on February 07, 2025. 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: 2025-02-07
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details multiple observations from an inspection, primarily concerning the sterile manufacturing of drug products.

**Facility and Operations:** The firm produces sterile drugs, including Trimix Gel for Intraurethral Insertion and various injectable vials (e.g., Trimix, Bimix, FSH, Hexarelin, hCG, NAD+). Operations involve ISO 5, ISO 7, and ISO 8/7 areas, as well as unclassified areas.

**Violations and Observations:**

1.  **Sterile Drug and Material Exposure to Sub-ISO 5 Air:**
    *   Trimix Gel is prepared using non-sterile, uncapped syringes sterilized in an unclassified area. After sterilization, opened syringes are capped with "sterile" caps before transfer to ISO 8/7 and ISO 5 areas, lacking assurance of sterility maintenance in uncontrolled environments.
    *   Drug product vials are transferred from an ISO 5 BSC through an ISO 7 area to a [redacted] within the ISO 7 area, exposing sterile products to air worse than ISO 5.

2.  **Microbial Contamination:**
    *   Failure to add routine environmental monitoring for mold, yeast, and spore-forming microorganisms in ISO 5 and ISO 7 areas.
    *   Recoveries of *Paenibacillus glucanolyticus* (TNTC CFU) in ISO 7 prep cleanroom (01/

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

- [Jazmine N. Brown](https://www.keypedia.com/people/jazmine-n-brown/194fc53f-942f-4e8c-a475-b7eac11be103)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c