FDA EIR - Universal Preserv-A-Chem Inc. - July 22, 2021

An FDA inspection was conducted at Universal Preserv-A-Chem Inc. in Mebane, NC, on July 22, 2021. This limited-scope inspection focused on the company's re-packaging and warehousing of dietary supplement ingredients and food additives. The regulatory oversight was performed under the Preventive Controls and Sanitary Human Food Operations and Dietary Supplements Imported and Domestic frameworks, emphasizing Good Manufacturing Practices. The inspection revealed no formal regulatory violations, as an FDA Form 483 (Inspectional Observations) was not issued. During the close-out discussion with management, one minor concern was noted: observable gaps existed underneath shipping doors three and four. Management confirmed these gaps resulted from doors not being completely shut and committed to addressing the issue. The company pledged to implement corrective training for employees to ensure proper closure of shipping doors, thereby eliminating future gaps. The inspection also covered the firm's Standard Operating Procedures for various operations, including material purchasing, receiving, re-packaging, labeling, and warehousing, with no discrepancies noted in these areas.