21 C.F.R. § 26.13 Transmission of postapproval inspection reports.
Title 21 - Food and Drugs
Postapproval good manufacturing practice (GMP) inspection reports concerning products covered by this subpart will be transmitted to the authority of the importing country within 60-calendar days of the request. Should a new inspection be needed, the inspection report will be transmitted within 90-calendar days of the request.
Title 21: Food and Drugs
PART 26—MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
Subpart A—Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices
§ 26.13 Transmission of postapproval inspection reports.
