KRS Global Biotechnology, Inc – FDA 483, Mar 17, 2014

The FDA Form 483 documents observations from an inspection, highlighting significant deficiencies in the facility's sterile drug product manufacturing processes.

**Facility and Operation Details:** The inspection observed the production of various sterile drug products, including Bimix #10 (Papaverine/Phentolamine), Dropedirol, Human Chorionic Gonadotropin, Cyanocobalamin, Carnitine (L), and Methionine/Inositol/Choline.

**Violations and Observations:**

* **Sterilization Process Validation (21 CFR 211.113(b)):** * Procedures 07.31.01 and 03.42.01 for sterilization and depyrogenation of vials and glassware lack full validation for all drug product contact surfaces. * Specific examples include the absence of (b) (4) for auto dispenser transfer tubing, glassware, vials, and stoppers, and lack of validation using appropriate (b) (4) (b) (4). * Depyrogenation of these items was not validated using a known endotoxin standard to demonstrate a three-log reduction. * The firm does not perform or require (b) (4) to ensure proper function of the (b) (4) used to sterilize drug products from nonsterile components. An instance was observed on 3/5/201