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 its petition, AHPA notes 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."
"The herbal products industry and FDA share an interest in ensuring compliance with cGMP rules, both for dietary supplement facilities under the current rule and for food facilities that will soon need to comply with entirely new rules," said AHPA President Michael McGuffin. "Adoption by FDA of the common sense approach requested by AHPA would contribute to the realization of this shared goal.