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# FDA Denies Food and Supplement Inspection Petition
- URL: https://www.fdaweb.com/fda-denies-food-and-supplement-inspection-petition/
- Published: 2016-08-04T12:00:00.000Z
- Updated: 2026-09-14T21:21:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136409

FDA has denied a 10/17/13 petition from the American Herbal Products Association asking that it **(1)** formally rescind an agency policy prohibiting investigators from quoting or citing cGMP (current good manufacturing practice) regulations upon which they base inspection findings reported in FDA-483 issued to conventional food and dietary supplement facilities; and **(2)** revise the Inspection Operations Manual to require that 483s issued to conventional food and dietary supplement facilities reference each cGMP to which the investigator’s listed observations relate.

The denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2013-P-1291-0004&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) says that the agency has no such policy and cannot rescind a policy that it does not have. “While investigators are limited to recording their factual observations on FDA-483s,” it says, “they are encouraged to relate each listed condition to the applicable sections of law and regulations administered by FDA in their discussions with firm management.”

FDA also declined to revise the inspection observations manual because, it said, the current practice furthers agency interests and promotes understanding, compliance, and transparency.