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# Compliance Guide for Some Combination Products
- URL: https://www.fdaweb.com/compliance-guide-for-some-combination-products/
- Published: 2020-06-04T12:00:00.000Z
- Updated: 2026-09-14T16:17:06.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5146938

FDA has issued a compliance guide for inspections of CDER-led or CDRH-led combination products. The [document](https://www.fda.gov/media/138592/download?ref=fdaweb.com) says that a single establishment inspection report and, where applicable, FDA-483 should be used to document all observations made during an inspection at a combination product manufacturer.

The guide’s contents include Background; Implementation; Inspectional; Analytical; Regulatory/Administrative Strategy; References, Attachments, and Program Contacts; Center Responsibilities; and Attachments.