FDA EIR - Tishcon Corp - April 12, 2022

A routine, comprehensive FDA inspection was conducted at Tishcon Corp., a dietary ingredient importer and contract manufacturer of dietary supplements in Westbury, NY, from April 5-12, 2022. The inspection, aligning with regulatory frameworks for dietary supplements, seafood, and preventive controls, covered operations including food defense plans, fish oil importation, and Omega Q Plus 100mg of CoQ10 Resveratrol dietary supplement manufacturing. It also involved a thorough review of the firm's standard operating procedures, batch records, ingredient and finished product testing, employee training, customer complaints, and sanitation monitoring.During a previous inspection in November 2017, Tishcon Corp. received an FDA-483 for failing to verify finished product specifications, not rejecting non-conforming components, and inadequate documentation for in-process controls. The firm addressed these prior observations, and their corrective actions were verified as implemented and effective during the current inspection.Notably, the recent inspection concluded without the issuance of an FDA-483 Inspectional Observations form, indicating no new significant issues or violations were identified. No sanitation deficiencies were observed, and management was reminded to renew the firm's registration by the end of 2022. This signifies that Tishcon Corp. was found to be operating in compliance with current regulatory standards.