Randol Mill Pharmacy – FDA Warning Letter, Aug 6, 2019

On September 17, 2020, the FDA issued a Warning Letter to Randol Mill Pharmacy following an inspection from July 23 to August 6, 2019. The inspection revealed that drug products produced by the pharmacy failed to meet the conditions for exemption under Section 503A of the FDCA, specifically by not receiving valid prescriptions for individually-identified patients for products like LIPOTROPIC INJ. SOL and BENZ/LID/TET ANHY 20/6/10%. This renders these products ineligible for exemptions from CGMP, adequate labeling, and FDA approval requirements.

The FDA also cited serious deficiencies in sterile drug product production, leading to adulterated products under Section 501(a)(2)(A) of the FDCA due to insanitary conditions. Violations included personnel exposing skin in ISO 5 areas, inadequate disinfection of materials, failure to conduct post-use testing on sterilization filters, media fills not performed under challenging conditions, inadequate smoke studies, visibly dirty surfaces in the ISO 5 area, and improper handling of hazardous drug products.

Furthermore, the ineligible drug products were found to be adulterated under Section 501(a)(2)(B) of the FDCA due to significant CGMP violations, such as failure to establish adequate cleaning/disinfecting systems, inappropriate personnel clothing, lack of validated aseptic/sterilization procedures, inadequate segregation, lack of stability