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

Source: https://www.keypedia.com/records/warning_letter/fusion-iv-pharmaceuticals-inc/d500e428-06c4-4ecf-974a-2ad4d5069766

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

---

## Details

- Record Type: WARNING_LETTER
- Company Name: fusion iv pharmaceuticals, inc. 
- Inspection Date: 2017-03-23
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: On February 21, 2018, the FDA issued a Warning Letter to Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical, an outsourcing facility registered under section 503B of the FDCA since January 6, 2017. This letter followed an inspection from March 13-23, 2017, which revealed serious deficiencies in sterile drug product production and failure to meet 503B conditions.

Violations included compounding drugs using bulk substances not on the 503B bulks list or drug shortage list (e.g., GHRP-2, GHRP-6, serotonin HCl, testosterone cypionate, DMSO, DHEA, HCG, nandrolone, phosphatidylcholine, sermorelin). Labeling deficiencies were noted, such as missing "Office Use Only" for non-prescription products and absence of adverse event reporting information (www.fda.gov/medwatch and 1-800-FDA-1088). The facility also failed to submit required product reports upon initial registration (January 2017) and in June and December 2017.

Drug products were deemed adulterated under FDCA sections 501(a)(2)(A) due to insanitary conditions, including continued commercial production despite media fill failures (turbidity, particulates) and lack of media fills for an automated vial filling machine. Products were

## Related Documents

- [483 - 2017-03-23](https://www.keypedia.com/records/483/fusion-iv-pharmaceuticals-inc/5c2bef54-da8e-4eb8-b56e-48e26b36e583)
- [483 - 2017-03-23](https://www.keypedia.com/records/483/fusion-iv-pharmaceuticals-inc/5e95b24f-f362-4742-b473-cf59b6881ef9)
- [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

- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

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