# FDA 483 - fusion iv pharmaceuticals, inc.  - March 23, 2017

Source: https://www.keypedia.com/records/483/fusion-iv-pharmaceuticals-inc/5e95b24f-f362-4742-b473-cf59b6881ef9

> FDA 483 for fusion iv pharmaceuticals, inc.  on March 23, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: fusion iv pharmaceuticals, inc. 
- Inspection Date: 2017-03-23
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA Form 483 details numerous deficiencies at an outsourcing facility producing sterile drug products.

**Facility and Operations:** The facility utilizes ISO 5 Laminar Flow Workstations (LAFWs) and an ISO 5 filling room with a PennTech automated vial filling machine. Products include Total Parenteral Nutrition (TPN), Methylcobalamin, Methionine/Inositol/Choline (MIC) Injectable, Testosterone Cypionate, Human Chorionic Gonadotropin (HCG), Hydroxocobalamin, Methylprednisolone Acetate, Chromium Picolinate, Ascorbic Acid, B-Complex, Cyanocobalamin, Pyridoxine Hydrochloride, Glutathione, Triamcinolone Diacetate, and Dexamethasone LA.

**Violations and Observations:**
*   **Sterility Failures & Investigations:** Failure to investigate root causes of media fill sterility failures in ISO 5 LAFWs from (b)(4), with observed turbidity in growth promotion media.
*   **Media Fill Validation:** No media fill validation runs performed on the PennTech automated vial filling machine, despite producing (b)(4) batches of sterile drug products between (b)(4).
*   **Environmental Control:** No Smoke Pattern Test performed in the ISO 5 Filler Room. An individual's arm was observed obstructing unidirectional airflow during TPN preparation in an ISO 5 workstation.
*   **Growth Media Testing:** Failure to perform growth media

## Related Documents

- [483 - 2017-03-23](https://www.keypedia.com/records/483/fusion-iv-pharmaceuticals-inc/5c2bef54-da8e-4eb8-b56e-48e26b36e583)
- [WARNING_LETTER - 2017-03-23](https://www.keypedia.com/records/warning_letter/fusion-iv-pharmaceuticals-inc/d500e428-06c4-4ecf-974a-2ad4d5069766)
- [AMENDED_483 - 2019-12-02](https://www.keypedia.com/records/amended_483/fusion-iv-pharmaceuticals-inc/cf825ad2-2b01-4ae3-8c4e-44a78d7120d0)
- [483 - 2019-12-20](https://www.keypedia.com/records/483/fusion-iv-pharmaceuticals-inc/1f7a8f3c-2be7-40da-a404-9aa0bacc3847)
- [483 - 2017-03-23](https://www.keypedia.com/records/483/fusion-iv-pharmaceuticals-inc/6c4ee784-5244-41d6-bcf6-598db7e5cbb7)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)
- [Investigator](https://www.keypedia.com/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)
- [SVP Consulting & Operations](https://www.keypedia.com/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

Company: https://www.keypedia.com/companies/fusion-iv-pharmaceuticals-inc/c1ced97a-5665-4304-9421-6b2ff8df4615

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