# FDA 483 - Medistat RX, LLC - September 23, 2015

Source: https://www.keypedia.com/records/483/medistat-rx-llc/fb62215b-0fb1-4d63-9e06-09e4ecaf0b92

> FDA 483 for Medistat RX, LLC on September 23, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medistat RX, LLC
- Inspection Date: 2015-09-23
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: The FDA Form 483 details numerous violations at an unnamed facility producing injectable drug products.

**Key Violations and Observations:**

*   **Inadequate Investigation of Discrepancies:**
    *   Environmental monitoring failures (gram-negative bacteria, yeast, mold in ISO 5 hoods) were not adequately investigated.
    *   Multiple drug product lots (Methylprednisolone, Triamcinolone Acetonide, Tri-Mix, HCG, Testosterone Cypionate/Propionate) were released after initial failing sterility results, with investigations concluding "laboratory error" or "analyst error" without sufficient evidence. Products were re-tested by alternative labs and released.

*   **Deficient Aseptic Processing Procedures:**
    *   Injectable drug suspensions are sterilized using unvalidated processes and equipment (redacted) in the ISO 8 Prep Room, lacking qualification, cycle validation, and redacted studies.
    *   Operators exhibited poor aseptic technique: handling non-sterile items and resuming compounding without re-sanitizing, pouring non-sterile Benzyl Alcohol into de-pyrogenated containers, and improper hand/finger placement over open vials and during stopper application within ISO 5 hoods.
    *   Smoke studies for clean rooms (including ISO 5 areas) are not performed in static or dynamic conditions.
    *   The redacted used for redacted testing lacks calibration documentation.
    *   No viable air monitoring is conducted within the ISO

## Related Officers

- [Misty M. D’Ottavio, RN](https://www.keypedia.com/people/misty-m-dottavio-rn/12e483b9-6e04-42f9-9e9b-5c550597fbd7)
- [ Drug Investigator](https://www.keypedia.com/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)

Company: https://www.keypedia.com/companies/medistat-rx-llc/4a9be3cd-158f-49a2-8e27-6123a71ceaba

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea