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# Elite Laboratories PADE Reporting Violations
- URL: https://www.fdaweb.com/elite-laboratories-pade-reporting-violations/
- Published: 2016-09-27T12:00:00.000Z
- Updated: 2026-09-14T21:35:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136919

A 1/5-2/2 FDA inspection of Elite Laboratories, Northvale, NJ, found serious violations of the Postmarketing Adverse Drug Experience (PADE) reporting requirements, according to a just-released 9/25 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521289.htm?ref=fdaweb.com) from the agency’s New Jersey District Office. Specifically, the letter says, the firm failed to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences. The firm’s written response was inadequate, FDA says, because it failed to address the root causes and impact of the inspection observations and failed to describe how Elite will monitor and review its actions to ensure effectiveness and prevent recurrence.

“We are concerned about your firm’s fundamental understanding and implementation of PADE regulations,” the letter says. “As the application holder of 11 ANDAs, you are ultimately responsible for ensuring compliance with the \[Federal Food, Drug, and Cosmetic Act\] and PADE regulations. The lack of adequate written procedures observed during the inspection and examples of failure to report safety information to FDA in a complete, accurate, and timely manner raises concerns about your firm’s ability to assess the safety of your drug products.”

Elite was told to take prompt action to correct the violations and to respond with a list of specific actions taken, documentation of each action, and a timetable for completion.