The Food and Drug Administration has told a compounding pharmacy in Florida that investigators found serious deficiencies in the pharmacy’s practices for producing sterile drugs, according to a warning letter posted Aug. 27 on FDA’s website.
FDA also said that another compounding pharmacy in Irvine, Calif., is voluntarily recalling two lots of drug products because laboratory tests to assess sterility may be inaccurate.
In the warning letter, FDA said its investigators conducted an inspection of Balanced Solutions Compounding in Lake Mary, Fla., from March 12 to March 15. Balanced Solutions Compounding is part of Axium Healthcare Pharmacy.
The agency said ...
Learn more about Bloomberg Law or Log In to keep reading:
See Breaking News in Context
Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.
Already a subscriber?
Log in to keep reading or access research tools and resources.