FDA 483 - Surgery Pharmacy Services Inc - July 07, 2023

This FDA Form 483 was issued to Surgery Pharmacy Services Inc, a producer of sterile drug products located at 3908 Tennessee Ave Ste F, Chattanooga, TN. The inspection, conducted from June 20 to July 7, 2023, by Investigator Jared P Stevens, identified three observations.

Observation 1 noted inadequate smoke studies under dynamic conditions. Videos from April 13, 2023, failed to show manipulations representative of actual compounding processes using the [(b)(4)], such as additions of small volumes, TPN bag connections, powered-on equipment, and connections to all component stations.

Observation 2 cited the failure to conduct media fills that closely simulate aseptic production operations under worst-case, most-challenging, and stressful conditions. Specifically, media fills did not reproduce manipulations made during production, such as the addition of small volumes via the [(b)(4)] machine.

Observation 3 indicated that the facility's design and operation might permit the influx of lesser quality air into a higher quality air area. Material flow directly from an unclassified area into an ISO 7 classified sterile production room occurred via an unfiltered [(b)(4)]. On June 21, 2023, materials (calibration kit, tubing, bags) entered the ISO 7 area, and finished TPN products exited, through this unfiltered [(b)(4)], which was approximately three feet from an ISO 5 hood used