FDA WARNING_LETTER - Green Hills Health and Wellness Pharmacy Inc - October 22, 2014

On October 14-22, 2014, the FDA inspected Green Hills Health and Wellness Pharmacy, Inc., identifying serious deficiencies. The firm was producing drug products without valid patient-specific prescriptions, violating Section 503A of the FDCA, rendering these drugs unapproved new drugs and misbranded under Sections 505(a) and 502(f)(1).

Investigators also observed insanitary conditions during sterile drug production, including the use of non-sterile cleaning agents for aseptic areas, causing products to be adulterated under Section 501(a)(2)(A). Furthermore, significant CGMP violations were noted, adulterating drugs under Section 501(a)(2)(B). These violations included failure to establish and follow procedures for preventing microbiological contamination (21 CFR 211.113(b)), inadequate cleaning/disinfecting systems (21 CFR 211.42(c)(10)(v)), insufficient environmental monitoring (21 CFR 211.42(c)(10)(iv)), lack of final product testing for sterile/pyrogen-free drugs (21 CFR 211.167(a)), and inadequate stability testing programs (21 CFR 211.166(a)).

The firm's November 11, 2014, response to the FDA 4