The citizen petition requests that the agency begin citing specific regulations connected to inspection observations on FDA Form 483s that are issued to companies in food and dietary supplement facility inspections. The agency already cites specific regulations if a 483 progresses to the warning letter stage, McGuffin notes.
McGuffin emphasized that the petition, to which FDA is required to respond in one form or another, was meant in the spirit of helpful cooperation.
“We submitted this with the thought that the agency will say this is a good idea,” McGuffin told NutraIngredients-USA.
No specific citations
When FDA inspects a regulated facility and finds significant objectionable conditions, including significant violations of the current Good Manufacturing Practice (cGMP) regulations, FDA issues a Form 483 to the firm's management. Current FDA policy included in the agency's Investigations Operations Manual (IOM) forbids investigators from citing the specific regulations applicable to the observations included on the form. As a result, when a firm receives a Form 483, it may not know what regulation FDA considers to be applicable to the observation on the form.
In the petition, AHPA said that including references to the regulation relevant to each observation recorded on the form would "improve transparency, understanding, and compliance" with cGMP regulations. The petition also states that inclusion of such information "would assist the regulated industry in coming into compliance with FDA regulations and thereby promote the rationale underlying their promulgation."
Learning curve for food facilities, too
McGuffin said the issue came up as AHPA was getting together its comments on the draft rules recently issued by FDA on implementation of the Food Safey Modernization Act (FSMA).
“The reason we decided to extend this from dietary supplements to conventional foods is that the new FSMA rules, when they come totally into play, are going to completely change the world of food manufacturing,” McGuffin said.
“The same kind of learning curve is going to confront the food industry. We believe that FDA starts food facility inspections they are going to encounter the same kind of thing that we are encountering now in dietary supplements. Companies that believe they are in compliance and find they are not are going to need some guidance in determining what is the specific rule that applies.
“We believe that by knowing what they need to comply with, it will assist companies in coming into compliance,” McGuffin said.