CFR section

21 CFR 820.100(a)(7): Corrective and preventive action

PART 820-QUALITY SYSTEM REGULATION · Subpart J-Corrective and Preventive Action

Key facts

Citation 21 CFR 820.100(a)(7)
Section Corrective and preventive action
Part PART 820-QUALITY SYSTEM REGULATION
Subpart Subpart J-Corrective and Preventive Action
Subchapter 21 CFR H Medical Devices
Product types cited Devices, Drugs, General
Regulation text (excerpt) (7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.

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