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DEPARTMENT OF HEAL TH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DATE($) OF INSPECTION DISTRICT OFFICE ADDRESS AND PHONE NUMBER. S. Food and Drug Administration, ORA/OPO/Division IV I 970 I Fair

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What is quality system observation l?

Quality system observation l is a tool used to identify issues or areas of improvement within a quality system.

Who is required to file quality system observation l?

Companies or organizations that have a quality system in place are required to file quality system observation l.

How to fill out quality system observation l?

Quality system observation l can be filled out by documenting any observations or findings related to the quality system.

What is the purpose of quality system observation l?

The purpose of quality system observation l is to improve the overall quality and performance of a system.

What information must be reported on quality system observation l?

Information such as observations, findings, recommended actions, and follow-up plans must be reported on quality system observation l.

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