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# Compounding Violations at Medical Center Pharmacy
- URL: https://www.fdaweb.com/compounding-violations-at-medical-center-pharmacy/
- Published: 2017-08-01T12:00:00.000Z
- Updated: 2026-09-14T22:37:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139268

A 9/28/15-10/13/15 FDA inspection at Medical Center Pharmacy, Cleveland, TN, found serious deficiencies in the firm’s practices for producing sterile drug products, which put patients at risk, according to a 7/21 Warning Letter from the agency’s Office of Pharmaceutical Quality post in Dallas, TX. Specific violations noted in the letter were: 

· failing to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions;

· 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;

- failing to establish an adequate system for monitoring environmental conditions in the aseptic processing area;
- 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 adequately design the facility with adequate separation or defined areas or such other control systems necessary to prevent contamination or mix-ups;
- failing to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed; and
- failing to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination.

The letter says the firm’s compounded drug products are misbranded because they are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners.

FDA recommends that Medical Center Pharmacy’s management undertake a comprehensive assessment of its operations, including facility design, procedures, personnel, processes, materials, and systems, with a particular focus on aseptic processing operations. It suggests that a third-party consultant with relevant sterile drug manufacturing expertise could be useful in conducting the comprehensive evaluation.

The pharmacy was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with related documentation and a timetable for completion.