General Requirements

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. General
  6. General Enforcement Regulations
  7. Establishment, Maintenance, and Availability of Records
  8. General Requirements

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Section
1.360

What are the record retention requirements?

Section
1.361

What are the record availability requirements?

Section
1.362

What records are excluded from this subpart?

Section
1.363

What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?