FDA 483 - KRS Global Biotechnology, Inc - October 23, 2017

This FDA Form 483 details observations from an inspection concerning the manufacture, processing, packing, or holding of drug products. The facility uses Water for Injection (WFI) for drug preparations like Phenylephrine HCl/Tropicamide 2.5%/1% and Magnesium Chloride hexahydrate/selenium/calcium gluconate since mid-2015.

Key violations include: 1. **Equipment Design and Maintenance:** Equipment is not of appropriate design for cleaning and maintenance. Specifically, the firm lacks documentation (protocol/report) for WFI system cleaning validation. The (b) (4) clean process lacks data showing parameter achievement throughout the system (skid to POU) and written procedures for process parameters, acceptance criteria, and verification of completion. No written procedures exist for chemical sanitization (sanitizer, concentration, application, acceptance criteria) used as corrective action. Records for maintenance, cleaning, sanitizing, and inspection of WFI, deionized (DI), and laboratory water systems were unavailable.

2. **Failure to Review Discrepancies/OOS:** The firm failed to thoroughly review unexplained discrepancies and out-of-specification (OOS)/out-of-trend (OOT) results. Microbial contamination in WFI samples since 2016 (e.g., WFI06082017, WFI01252017, WFI0