Nubratori Inc. dba Nubratori Rx – FDA Warning Letter, Jul 26, 2024

On January 22, 2025, the FDA issued Warning Letter #700513 to Nubratori, Inc. dba Nubratori Rx, an outsourcing facility registered under section 503B of the FDCA. An inspection from July 16-26, 2024, revealed serious deficiencies in drug production practices, leading to adulterated drug products under sections 501(a)(2)(A) and 501(a)(2)(B) of the FDCA.

Violations include insanitary conditions, such as inadequate personnel sampling (glove fingertip sampling after sanitization), and multiple CGMP violations: 1. Failure to establish adequate acceptance criteria for quality control testing (21 CFR 211.165(d)). 2. Failure to follow written procedures to prevent microbiological contamination of sterile drug products (21 CFR 211.113(b)). 3. Failure to establish an adequate environmental monitoring system in aseptic processing areas (21 CFR 211.42(c)(10)(iv)). 4. Failure to follow written procedures for equipment cleaning and maintenance (21 CFR 211.67(b)). 5. Failure to conduct microbiological testing of components with potential for objectionable contamination (21 CFR 211.84(d)(6)). 6. Failure to