June 2020/1 - FDA Combination Products Inspection Program

A few days ago, the FDA has published their Compliance Program 7356.000 (LINK) for the inspection of CDER-led or CDRH-led (Drug Device) Combination Products. The document provides insight in the division of responsibilities of the involved FDA offices, the followed inspection approach and topics to be covered during the inspection. In addition, so-called “inspectional considerations” are provided in the annexes, for the verification of the 21 CFR 211 requirements of a combination product manufacturer that utilize the device QS regulation (21 CFR 820) as their base, and – vice versa – the 21 CFR 820 requirements for manufactures that utilizes a drug based QS (21 CFR 211).

All in all, for those operating in the field of Drug - Device combination products, this document is a useful resource to gain insight of, and get prepared for FDA inspections for these products.

Lucas GxP Consultancy has experiences with FDA Combination Product inspections and can help your organization in preparing for such an inspection. For more information, please contact Lucas GxP consultancy on +31 6 36258806 or submit an email to hans.lucas@gxpconsultancy.com

Note: In 2017 the FDA already issued a Warning Letter to a combination product manufacturer referencing deficiencies related to both 21 CFR 211 and 21 CFR 820 requirements. The letter can be found HERE.