FDA 483 - Ecotec Manufacturing, Inc. - April 18, 2023

Ecotec Manufacturing, Inc., located in Okeechobee, FL, underwent an FDA inspection from April 18 to April 20, 2023. This inspection resulted in the issuance of a Form FDA 483, identifying two significant observations concerning the company's quality system practices.

The first observation highlighted that document control procedures were not adequately established. Specifically, the existing "Control of Documents Process" did not align with the company's current document numbering system. Furthermore, the new numbering system was being implemented without a formal, approved procedure in place.

The second observation noted a lack of established procedures for management review. This indicates a gap in the firm's formal process for regularly assessing the suitability, adequacy, and effectiveness of its quality system. These issues fall under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, which mandates proper controls for manufacturing facilities.

To address these findings, Ecotec Manufacturing is required to implement corrective actions. The company has committed to correcting both observed deficiencies, which is crucial for ensuring operational compliance and maintaining product quality and safety.