Med Shop Total Care, Inc. — FDA Warning Letter Findings

Your firm failed to establish an adequate contact time for a disinfecting agent used in your aseptic processing areas.

In response to Observation 5, we acknowledge your statement, “In an effort to reduce movement in and out of the hood, we are currently testing computer keyboards that are designed for clean room areas, and which may be kept inside the hood, so that logging information can be conducted during our processing.” However, your response is inadequate as it does not indicate a timeframe for implementation or any appropriate interim actions to address this concern. Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A. FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation. D.

Regarding your response to Observation 1, your response is inadequate. Any microbial contamination in the ISO 5 area is considered an insanitary condition. Any microbial contamination within the ISO 5 area is a serious concern and upon recovery, your firm should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and over what period of time the contamination…

An operator placed their gloved hands outside the ISO 5 aseptic processing area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood.

You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.

A brownish residue on the protective screen of the HEPA filter within your ISO 5 aseptic processing area. It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated. C. Corrective Actions We have reviewed your firm’s response to the Form FDA 483. Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, the following corrective actions appear deficient…