21 CFR 211.80 - General Requirements - Component and Container Receipt

What it says

Written procedures must describe the receipt, identification, storage, handling, sampling, testing and approval or rejection of components and drug product containers and closures, with each lot held in quarantine until approved for use, and containers and carriers examined visually for damage or contamination upon receipt.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Quarantine status until approval is a physical or systematic control, not just a paperwork designation - unapproved material must be genuinely unavailable for use in production, not merely labeled as pending.
• Visual examination upon receipt is an explicit, distinct step from later sampling and testing, intended to catch obvious damage or contamination before the material even enters the formal testing workflow.
• This provision connects directly to supplier qualification and testing requirements under 211.84, forming the front end of the incoming material control system.

What FDA inspectors look for

• Whether quarantined material is physically or systematically segregated in a way that genuinely prevents its use before formal approval, not just administratively flagged.
• Whether incoming shipment visual examination is documented and performed consistently, catching damage or contamination issues before material enters storage.
• Whether chain of custody from receipt through quarantine to approved status is traceable for each specific lot.

Related regulations