FDA 483 - Stonegate Pharmacy LP - June 11, 2018

On June 11, 2018, the FDA issued a Form 483 to Stonegate Pharmacy LP, a producer of sterile and non-sterile drug products located at 2501 W William Cannon Dr Ste 203, Austin, TX 78745-5255. The inspection, conducted from May 30 to June 11, 2018, identified four observations.

Observation 1 noted that media fills did not adequately simulate aseptic production, worst-case activities, or challenging conditions. For example, media fills involved placing (b)(4) units, while routine production included batches of Glutathione 5% Inhalation Solution (b)(4) units and Chorionic Gonadotropin 10000IU/ml Solution (b)(4) vials, with routine batch sizes exceeding (b)(4) and various vial sizes (2ml-100ml). This was a repeat observation from a 2016 inspection.

Observation 2 detailed a personnel hand washing procedure that risked gowning apparel contamination. On June 5, 2018, a sterile technician washed hands in the ISO7 anteroom, with tap water splashing onto her scrubs and the floor. She then donned sterile garments without changing shoe covers, which may have been contaminated and entered the ISO7 buffer room.

Observation 3 stated that (b)(4) were not properly