# FDA 483 - SterRx, LLC - June 28, 2023

Source: https://www.keypedia.com/records/483/sterrx-llc/12f940a3-e4fb-4d6b-b215-e997775f462e

> FDA 483 for SterRx, LLC on June 28, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SterRx, LLC
- Inspection Date: 2023-06-28
- Product Type: Drugs
- Office Name: New York District Office
- Summary: The FDA Form 483 inspection revealed multiple deficiencies at a facility manufacturing sterile drug products in Blow-Fill-Seal (BFS) IV bags.

**Facility and Operations:** The facility produces sterile drug products, including 150 MEQ Sodium Bicarbonate D5W Injection and 0.2mg Fentanyl/0.125% Bupivacaine in 0.9% Sodium Chloride, using BFS (Equipment # E0581), Capper (Equipment # E0602), and Bag Filling/Sealing Machine (Equipment # E0655).

**Violations and Observations:**
*   **Contamination Prevention (21 CFR 211.80(b)):** Failure to maintain sterility of the cap and interstitial space of BFS IV bags, which cannot be sanitized by the user.
*   **Protective Apparel (21 CFR 211.28(a)):** An operator in non-sterile garb (hood, face mask, safety glasses, coverall) entered the ISO 5 space during an intervention on 06/02/2023, with exposed skin around safety glasses and hood/mask borders.
*   **Environmental Monitoring (21 CFR 211.42(c)(10)(iv)):** The environmental monitoring program for BFS and Capper lacks direct monitoring of caps during transfer to the capping/sealing

## Related Documents

- [483 - 2017-03-17](https://www.keypedia.com/records/483/sterrx-llc/e41dd598-3c13-494f-9de5-237aeec71392)
- [483 - 2021-11-04](https://www.keypedia.com/records/483/sterrx-llc/4ad16f6a-2d70-4d20-889f-5400e1b3fec5)

## Related Officers

- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)
- [Investigator](https://www.keypedia.com/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.keypedia.com/companies/sterrx-llc/e044d9e8-9ead-4e6d-908e-2741f789519b

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d