# FDA 483 - Medistat RX L.L.C. - September 18, 2014

Source: https://www.keypedia.com/records/483/medistat-rx-llc/d701d53d-fda7-4b87-afb3-18fb49705c0e

> FDA 483 for Medistat RX L.L.C. on September 18, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medistat RX L.L.C.
- Inspection Date: 2014-09-18
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: The FDA Form 483 documents deficiencies at a facility engaged in sterile compounding and drug product manufacturing.

**Violations and Observations:**

*   **Aseptic Processing Deficiencies:**
    *   Environmental monitoring of laminar flow hoods, buffer rooms, and ante rooms is not conducted under dynamic conditions.
    *   No scientific rationale or written specifications (air exchange rates, particle counts, pressure differential) exist for classified rooms where sterile compounding occurs.
    *   Personnel and environmental monitoring are not performed daily when sterile products are made.
*   **Sterilization Process Validation:**
    *   The sterilization process is not validated.
    *   A specific (b)(4) unit, labeled for laboratory use only, is used to sterilize drug products from non-sterile components.
    *   Media fills do not simulate actual production quantities or different vial sizes.
*   **Product Release and Quality Control:**
    *   Drug products failing specifications are not rejected; two lots of Progesterone capsules failing potency were distributed without corrective action.
    *   Endotoxin testing is not conducted on each batch of injectable drug products made from non-sterile components.
    *   Growth promotion testing of agar and media for sterility analysis is not performed.
    *   Each lot/batch of drug product is not tested for potency of each active ingredient prior to release.
*   **Production and Process Controls:**
    *   No written procedures exist for

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Company: https://www.keypedia.com/companies/medistat-rx-llc/e77576a0-a271-4073-ae46-3dcd2f596423

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