THE COMPOUNDING SHOP, INC.: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.; Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Agency: Food and Drug Administration (FDA)

Event ID: 65125

Status: Resolved

Manufacturer: THE COMPOUNDING SHOP, INC.

Manufactured In: United States

Units Affected: 25 products (19 vials of 10ml; 80 vials of 4mL each; 1 vial of 22mL; 1 vial of 20mL and 1 vial of 40mL; 3 vials of 45mL; 20 vials of 5mL; 2 vials of 100mL; 41 vials of 2mL; 12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL; 43 vials of 250mL each; 7 vials of 50mL each; 55 vials of 100mL; 4 vials of 10mL each; 44 vials of 50mL each; 2 vials of 250mL and 26 vials of 100mL; 78 vials of 500ml and 92 vials of 100mL; 56 vials of 50mL; 32 vials of 50mL; 14 vials of 30mL each; 1 vial of 6mL, 19 vials of 10mL each and 1 vial of 40mL; 1 vial of 40mL; 1 vial of 40ml; 5 vials of 50mL; 10 vials of 30 mL each; 4 vials of 5mL and 22 vials of 10mL)