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

An unannounced FDA surveillance inspection of Eagle Labs, Inc., a contract manufacturer of foods, dietary supplements, cosmetics, and OTC drug products, took place from November 29, 2023, to December 6, 2023, in Seminole, FL. The inspection primarily focused on the manufacturing of their liquid dosage OTC drug product, Ninjacof Chlophedianol HCl/Pyrilamine Maleate.

The inspection identified two main objectionable conditions, documented on a Form FDA-483. Firstly, the company failed to adhere to its own written cleaning procedures for drug product equipment. This included not performing major cleans for the Ninjacof product filling equipment according to the defined schedule, processing multiple batches over nine days without the required comprehensive cleaning. Furthermore, there was a lack of specific cleaning instructions and validation for non-dedicated intermediate bulk storage drums used for both drug and dietary supplement mixtures. Secondly, the firm did not properly follow and document written production and process control procedures, specifically noting inadequate sampling documentation during the process validation of the Ninjacof OTC drug product.

These findings indicate non-adherence to current Good Manufacturing Practices (cGMP) regulations for drug products. Eagle Labs' management, led by Executive VP Mr. Abelardo L. Acebo and Director of Regulatory Affairs and QA Mr. Justin Ruch, committed to providing a written response to the FDA addressing these deficiencies within 15 business days. No product samples were collected, and no inspection refusals occurred.