# FDA 483 - MedisourceRx - October 22, 2020

Source: https://www.keypedia.com/records/483/medisourcerx/a1e1ffa0-3bb0-4b18-a86d-b3dda15cef25

> FDA 483 for MedisourceRx on October 22, 2020. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: MedisourceRx
- Inspection Date: 2020-10-22
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA Form 483 details multiple deficiencies observed during an inspection.

**Facility and Operation Details:** The document pertains to a drug product manufacturing facility producing Glutathione and Aviptadil, including both vial and syringe presentations. Operations involve 100% visual inspection, aseptic processing, media fills, and compounding.

**Violations and Observations:**

*   **Inadequate Discrepancy Review (Repeat Observation):** Major defects from 100% visual inspection were not thoroughly investigated.
    *   Unknown particles in multiple Glutathione and Aviptadil drug product lots were not identified.
    *   Investigations for media fill lots exceeding particulate action limits (e.g., Syringe lots (b)(4) and (b)(4)) were inadequate, with conclusions (e.g., aggregate from (b)(4) media) unconfirmed.
    *   No effort was made to identify particles in media fill vial product lots (e.g., lots (b)(4), (b)(4), (b)(4), (b)(4)).
    *   The (b)(4)% alert/action limits for major defects in visual inspection and discontinuation of (b)(4) inspection in drug product release were not justified.

*   **Inadequate Aseptic and Sterilization Process Validation:**
    *   Not all media fill units from Nov 2019 (syringes) and Feb 202

## Related Documents

- [483 - 2018-09-27](https://www.keypedia.com/records/483/medisourcerx/37374085-c2ea-4dec-8f59-bc0e62b5afa1)
- [483 - 2020-10-22](https://www.keypedia.com/records/483/medisourcerx/ccb3288b-e078-4a5b-9cd1-5526ca70de9d)
- [483 - 2025-06-10](https://www.keypedia.com/records/483/medisourcerx/a62ac39b-abb0-4a75-b0c8-d8990528dd22)
- [WARNING_LETTER - 2025-06-10](https://www.keypedia.com/records/warning_letter/medisourcerx/1fbda26f-82db-460c-9e19-19e6a0a63187)

## Related Officers

- [Professor](https://www.keypedia.com/people/liming-zhang/6c93b721-8725-4d87-8a42-254f3de5e49d)

Company: https://www.keypedia.com/companies/medisourcerx/9a855143-6076-4b52-a4e0-94d0d179a448

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b