FDA 483 - STAQ Pharma of Ohio, LLC - October 04, 2023

During an FDA inspection from September 18 to October 4, 2023, STAQ Pharma of Ohio, LLC, an outsourcing facility located at 255 Phillipi Rd, Columbus, OH, received a Form 483 with two observations.

Observation 1 noted a failure to conduct media fills that closely simulate aseptic production operations under worst-case conditions. Specifically, executed media fill lots used a (b) (4) mL fill volume in (b) (4) mL syringe configurations, which does not replicate the commercial batch production of (b) (4) mL fill volume in 10 mL syringes for products like Phenylephrine HCL (1000 mcg / 10 mL). The firm reportedly compounds no commercial product into (b) (4) mL syringes, only 10 mL syringes. While batch sizes were similar, the total volume filled for media fills was approximately (b) (4) compared to approximately (b) (4) for commercial lots.

Observation 2 identified deficiencies in the system for monitoring environmental conditions in aseptic processing areas. Viable and nonviable particle sample collection points inside the ISO-5 (b) (4) Laminar Flow Hood in room (b) (4) were inadequately situated directly adjacent to the HEPA air filter grate. This placement means samples evaluate only air immediately from the HEPA filter, not air representative of the operational sterile filling area where aseptic manipulations occur