21 CFR 211.82 - Receipt and Storage of Untested Components

What it says

Components, drug product containers and closures must be visually examined upon receipt, held under quarantine until sampled, tested or examined as appropriate, and released for use, with records maintained showing each lot's disposition.

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

What it means in practice

• Quarantine status under this provision is the physical and documented control that prevents untested materials from accidentally entering production, functioning as the first line of defense before the testing requirements in 21 CFR 211.84 even come into play.
• A receiving area that cannot reliably distinguish quarantined from released material is a common root cause behind incidents where untested components end up used in a batch.
• This provision's visual examination requirement at receipt is meant to catch obvious damage or contamination issues before a component even enters the testing queue, not to substitute for the testing itself.

What FDA inspectors look for

• Whether quarantine status is physically and visibly distinguishable from released status in storage areas, not just tracked on paper or in a system that floor personnel may not consult.
• Whether components are visually examined at receipt and whether findings from that examination are documented.
• Whether any instance of untested or quarantined material reaching production was investigated as a deviation.

Related regulations