Drugs

Hartley Pharmacy Cited for Multiple Violations

A 6/29-7/8/15 FDA Los Angeles District Office inspection at Hartley Medical Center Pharmacy, Long Beach, CA, found that the pharmacy was not receiving valid prescriptions for individually-identified patients for a portion of the drugs it produced. Investigators also observed serious deficiencies in the pharmacy’s practices for producing sterile drugs, according to a 4/21 Warning Letter. Violations discussed in the letter include:

failing to receive valid prescriptions for individually-identified patients for a portion of the drug products produced;
manufacturing and distributing unapproved new drugs;
manufacturing and distributing drug products that were intended or expected to be sterile and were prepared, packed, or held under insanitary conditions so that they may have been contaminated with filth or rendered injurious to health;
failing to have FDA-approved applications on file for drug products for which the pharmacy has not obtained valid prescriptions for individually-identified patients;
compounding drug products that are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners with labeling that fails to bear adequate directions for their intended use;
manufacturing and distributing adulterated drug products that were prepared, packed, or held under insanitary conditions;
failing to use a sporicidal agent or sterile wipes and using non-sterile sanitizers as part of the disinfection program for the aseptic processing area, creating an environment that poses a significant contamination risk;
failing to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
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 ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination;
failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes; and
failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

The letter acknowledges the pharmacy’s recall of several drug products and its numerous responses to the inspection report. “FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems,” it advises. “In particular, this review should assess aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation.”

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