21 CFR Part 1271
21 CFR Part 1271
21 CFR Part 1271
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Distribution – 2<br />
• Do not make available for distribution<br />
• Products in quarantine<br />
• Contaminated products<br />
• Product recovered from an ineligible donor<br />
• Donor pending full eligibility testing<br />
• If does not meet criteria designed to prevent<br />
disease transmission<br />
• Products manufactured under a deviation that<br />
risks contamination - unless a responsible<br />
person determines that there is no such risk –<br />
must be recorded and justified
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