FDA to Implement New Case Management SOP

FDA has provided Article 3 notice to NTEU that it will implement a new SOP regarding Case Management in OHAFO.

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FDA has provided Article 3 notice to NTEU that the Office of Human and Animal Food Operations (OHAFO) plans to implement a new Standard Operating Procedure (SOP) regarding Case Management. According to the notice, the SOP is a compilation of best practices obtained from SOPs that were used in the district offices prior to Program Alignment. The agency claims that the SOP will ensure uniform instructions for managing cases as well as consistency in all OHAFO division offices. The SOP will impact Compliance Officers and Compliance Support Staff, and there may be some involvement with Consumer Safety Officers when compliance requires additional information on events that occurred during an inspection or when there are questions on inspection reports. The SOP and the review checklist are available upon request.

NTEU has requested a briefing and to bargain this change. If you have any comments or questions, please share them with your chapter president.

Author: chapterpresident

I have worked in the FDA since 1990 in a variety of positions. I currently serve as chapter president of NTEU Chapter 254, representing FDA employees in Arkansas, Colorado, Iowa, Kansas, Missouri, Nebraska, New Mexico, Oklahoma, Texas, and Utah.