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The agency sent a warning letter to Cape Apothecary for adulterated drugs.
FDA issued a warning letter on August 12, 2016 to Cape Apothecary after an inspection uncovered microbial contamination at the Annapolis, MD facility. The company was cited for improper sterile manufacturing processes and unapproved new drug products.
During the inspection, investigators found deficiencies in sterile manufacturing practices. Investigators observed personnel not using a sporicidal agent, using non-sterile sanitizers in aseptic processing areas, and placing materials and components into the ISO 5 hood with ungloved hands. Environmental samples from multiple locations were collected by investigators. Test results of the samples found microbial contamination.
The agency found that the company had failed to establish an adequate system for maintaining equipment used to control aseptic conditions, failed to establish an adequate cleaning and disinfecting system, failed to monitor environmental conditions in aseptic processing areas, and failed to follow written procedures designed to prevent microbiological contamination. The company also failed to establish an adequate written testing program and to use stability testing results.
The company was also cited for not receiving valid prescriptions for individually identified patients for some of the drug products produced. “Because the domperidone drug products and drug products for which you have not obtained valid prescriptions for individually-identified patients are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA), and they are not exempt from the requirements of section 502(f)(1) of the FDCA [see, e.g., 21 CFR § 201.115],” the letter stated.
FDA recommends that company management “immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation.”