# FDA 483 - Nephron Sterile Compounding Center LLC - November 15, 2019

Source: https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/b90a675e-bc01-45a7-8205-6917e345158d

> FDA 483 for Nephron Sterile Compounding Center LLC on November 15, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nephron Sterile Compounding Center LLC
- Inspection Date: 2019-11-15
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: The FDA Form 483 details multiple deficiencies at a pharmaceutical facility.

**Sterility Testing and Procedures:**
*   Rapid sterility test procedures are inadequate: "background too high" samples (verbally defined as >X events) are discarded and product lots are released without investigation. This occurred ~23 times in 90 days.
*   No written definition of "background too high" or instructions for discarding/retesting.
*   Poor aseptic technique observed during sample preparation (e.g., passing hands over open containers).
*   No eye exam requirement for analysts reviewing rapid sterility results.
*   Analysts conducted commercial sterility testing before demonstrating ability to identify positive microbial events (e.g., one associate performed tests from Oct 3-29, 2019, but only saw a positive example on Oct 29).
*   No documentation of start/stop/elapsed incubation times for rapid sterility tests; only temporary notes on tape that are discarded.

**Aseptic Processing and Environmental Control:**
*   Failure to follow SOP.CM.4102 (Aseptic Processing and Technique):
    *   Operator observed opening Luer Lock IV Syringe Cap containers directly over cap scoop, blocking first air, and touching feeder with gloved hand.
    *   Operators sanitized gloved hands *before* personnel monitoring.
    *   Operator moved rapidly within ISO-5 Clean Room, causing tote and glo

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## Related Officers

- [Owner/Inspector](https://www.keypedia.com/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)
- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.keypedia.com/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)
- [Seneca D. Toms](https://www.keypedia.com/people/seneca-d-toms/3eda62a2-4c12-438f-805a-5e3efb0f2f94)

Company: https://www.keypedia.com/companies/nephron-sterile-compounding-center-llc/b9848542-bf88-4696-80c3-5fc545b76a92

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7