Latest FDA Warning Letter

FDA has posted its latest batch of Warning Letters that includes one medical product maker. It can be accessed by clicking on the link following the letter.

Fusion IV Pharmaceuticals (dba Axia Pharmaceutical) Los Angeles, CA (2/21): FDA inspected the drug outsourcing facility 3/2017 and it noted that compounded drug products produced failed to meet the conditions necessary for exemptions from certain agency regulations. In addition, FDA investigators noted serious deficiencies in the firm’s practices for producing sterile drug products. For example, the firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. Additionally, the firm does not have, for each batch of drug product purporting to be sterile or pyrogen-free, an appropriate laboratory determination of satisfactory conformance to final specifications for the drug products.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm605713.htm