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# Multiple Violations at Fusion IV Pharmaceuticals
- URL: https://www.fdaweb.com/multiple-violations-at-fusion-iv-pharmaceuticals/
- Published: 2018-05-01T12:00:00.000Z
- Updated: 2026-09-15T00:02:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141340

A 3/13-3/23/17 FDA inspection at Fusion IV Pharmaceuticals, a Los Angeles, CA, 503B outsourcing facility doing business as Axia Pharmaceuticals, found multiple violations, including that drug products produced by the firm failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic Act necessary for drugs produced by an outsourcing facility to qualify for exemption from certain provisions of the act, according to a just-released 2/21 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm605713.htm?ref=fdaweb.com). The letter also says agency investigators noted serious deficiencies in the firm’s practices for producing sterile drug products, which put patients at risk. The letter lists these violations: 

- compounding drug products using bulk drug substances not eligible for 503B exemptions because they are not on the 503B bulks list and are not used to compound a drug that is on the drug shortage list;
- some dispensed or distributed drugs other than pursuant to a prescription for an individually identified patient did not include an “Office Use Only” statement on the label and some did not include information on the container to facilitate adverse event reporting;
- · failing to submit a report to FDA upon registering as an outsourcing facility in 1/2017 and failed to submit six-month reports in 6/2017 and 12/2017 listing the drug products compounded during each reporting period;
- failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failing to have for each batch of drug product purporting to be sterile and/or pyrogen-free appropriate laboratory determination of satisfactory conformance to final specifications for the drug product;
- failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates;
- failing to have FDA-approved applications on file for drug products that are compounded;
- compounding drug products for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; and
- failing to report drugs that are compounded in six-month reporting periods.

The letter acknowledges the firm’s 7/12/17 recall due to CGMP deviations and lists the firm’s proposed corrective actions that appear to be deficient and those whose sufficiency cannot be evaluated due to a lack of adequate supporting documentation.

“FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems,” the letter says. “In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.”

Fusion IV was told to take prompt action to correct the violations and to respond with a list of specific steps taken, with documentation of each step and a timetable for completion.