FDA WARNING_LETTER - Vann Healthcare Services Inc - September 24, 2014

From September 8-24, 2014, an FDA inspection of Vann Healthcare Services, Inc. revealed serious deficiencies. The firm was producing drug products without valid prescriptions for individually-identified patients, violating Section 503A of the FDCA, which exempts certain compounded drugs from CGMP, labeling, and FDA approval requirements. Consequently, these drugs are misbranded under Section 502(f)(1) of the FDCA due to inadequate directions for use.

Furthermore, the inspection uncovered insanitary conditions during sterile drug production, causing products to be adulterated under Section 501(a)(2)(A) of the FDCA. Observed issues included an operator with exposed skin during sterile product production, failure to use a sporicidal agent in the ISO 5 area, and lack of studies demonstrating adequate protection by the hood in the ISO 5 area.

For drugs manufactured without individual patient prescriptions, the firm is subject to FDA's CGMP regulations (21 CFR Parts 210 and 211). Significant CGMP violations were noted, leading to adulteration under Section 501(a)(2)(B) of the FDCA. These violations include failure to establish procedures to prevent microbiological contamination (21 CFR 211.113(b)), ensure appropriate personnel clothing (21 CFR 211.28(a)), monitor environmental conditions (21 CFR