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FDA Guidance for Industry Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements


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

Document Type:
Guidance for Industry
responsibility to comply with Title 21 Code of Federal Regulations 1271.150(c)(1) (21 CFR 1271.150(c)(1)), if you enter into a contract, agreement, or other arrangement with another establishment to perform for you any step in manufacture.

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