# FDA 483 - SterRx, LLC - November 04, 2021

Source: https://www.keypedia.com/records/483/sterrx-llc/4ad16f6a-2d70-4d20-889f-5400e1b3fec5

> FDA 483 for SterRx, LLC on November 04, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SterRx, LLC
- Inspection Date: 2021-11-04
- Product Type: Drugs
- Office Name: New York District Office
- Summary: This FDA Form 483 documents observations from an inspection, highlighting multiple deficiencies in the facility's operations and quality systems.

**Facility and Operations:** The aseptic processing areas are deficient, lacking proper HEPA-filtered air supply under positive pressure. Specifically, the IV Bag filling line (Equipment # (b) (4)) and its enclosure do not provide first-pass HEPA-filtered laminar flow air over all critical ISO 5 classified areas.

**Violations and Observations:**
*   **Environmental Control:** Inadequate air supply and a deficient system for monitoring environmental conditions in aseptic processing areas.
*   **Equipment Design & Maintenance:** Equipment is not appropriately designed for cleaning and maintenance. Lubricants and coolants contact components/closures, potentially altering drug product safety, identity, strength, quality, or purity. Procedures for cleaning and maintenance are deficient in protecting clean equipment from contamination.
*   **Container Closure:** Container closure systems do not adequately protect against foreseeable external factors.
*   **Aseptic Processing Validation:** Procedures to prevent microbiological contamination lack adequate validation of the aseptic process.
*   **Personnel & Training:** Protective apparel is not worn as necessary to prevent contamination. Employees lack adequate training for their specific functions.
*   **Quality Control & Documentation:** Failure to thoroughly review unexplained discrepancies or batch failures. The written stability program lacks meaningful test methods. Complaint records are deficient, missing known replies to complainants.

**Critical Findings/Deficiencies:** The lack

## Related Documents

- [483 - 2017-03-17](https://www.keypedia.com/records/483/sterrx-llc/e41dd598-3c13-494f-9de5-237aeec71392)
- [483 - 2023-06-28](https://www.keypedia.com/records/483/sterrx-llc/12f940a3-e4fb-4d6b-b215-e997775f462e)

## Related Officers

- [Deputy Director](https://www.keypedia.com/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)
- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

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