FDA 483 - Eagle Labs Inc. - December 06, 2023

Eagle Labs Inc., a contract manufacturer, underwent an FDA inspection from November 29 to December 6, 2023. The inspection resulted in the issuance of a Form FDA 483, citing critical observations regarding the company's adherence to manufacturing standards.

The primary violations centered on the firm's failure to consistently follow established written procedures for equipment cleaning and maintenance. Specifically, Eagle Labs did not adhere to its own major cleaning schedule for a filling room, exceeding defined limits for continuous runs or batches. Furthermore, the company lacked specific cleaning instructions and validation protocols for non-dedicated drums used to hold drug and dietary supplement mixtures.

Another significant observation involved the inconsistent execution and documentation of written production and process control procedures. For instance, during the process validation of a drug product named NinjaCof, samples for in-process and finished product testing were not collected and documented precisely at the times specified in the approved protocol.

These findings highlight a necessity for Eagle Labs Inc. to promptly implement comprehensive corrective and preventive actions to ensure full compliance with federal regulations governing drug product manufacturing, as outlined by the Federal Food, Drug and Cosmetic Act. The company is expected to provide a detailed response addressing each observation.