The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Biotechnology Inspection Guide, November 1991


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

Document Type:
FDA Inspection Guide
These guidelines of ORA within FDA are not addressed to the industry but to the inspectors of FDA. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of manufacturers of biotechnology products.

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