FDA EIR - KRS Global Biotechnology, Inc - August 14, 2019

KRS Global Biotechnology, Inc. in Boca Raton, FL, was the subject of a For-Cause FDA inspection from July 30 to August 14, 2019. This inspection, which focused on the company's sterile and non-sterile drug compounding operations as an outsourcing facility, uncovered multiple significant deficiencies. It followed previous regulatory actions, including a 2015 FDA Warning Letter and prior observations related to inadequate water systems and general manufacturing practices.

The current inspection resulted in 14 observations on an FDA Form 483. Major issues included a lack of responsibility and authority within the quality control unit, and the absence of established procedures to prevent microbiological contamination in sterile products. Aseptic processing environments were found deficient regarding filtered air supply, environmental monitoring systems (with uninvestigated excursions), and inadequate cleaning and disinfection protocols, including the use of non-sterile agents. The company also lacked written procedures for production and process controls, failed to ensure appropriate stability data for drug product expiration dates, and did not perform adequate potency testing for non-sterile drugs. Additional concerns included deficient equipment calibration, complaint handling procedures, and container labeling. Deficient smoke studies demonstrated turbulent airflow and improper material transfer during critical aseptic operations. Management was informed of their obligation to achieve full compliance, with potential regulatory actions ranging from warning letters to injunctions if corrective measures are not effectively implemented. The firm committed to providing a written response within 15 business days.