RayzeBio, Inc — FDA 483 Findings

Master production and control records lack a statement of theoretical yield including the maximum and minimum percentages of theoretical yield beyond which investigation is required.

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.

Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Laboratory records do not include complete records of any testing and standardization of laboratory reference standards.

Equipment are not cleaned, maintained, sanitized or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.

Your firm failed to provide adequate system for cleaning and disinfecting the room and equipment to produce aseptic condition.

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet to any of its specifications Specifically, A.