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Compliance Quiz: 483 Notice of Observations

All 483 excerpts are from FY 2012 Inspectional Observation Summaries FDA.

1. Match the deviation description to the federal regulations reference number. 483 excerpt: “Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.”
2. Fill in the blanks: Federal regulation 21 CFR 111.455 (a) states that you must “hold [components] [dietary supplements] under appropriate conditions of temperature, ______ , or light so that their identity, purity, strength and ______ are not affected.”
3. Match the deviation description to the federal regulations reference number. 483 excerpt: “Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.”
4. Fill in the blanks: 21 CFR Section 211.142 “warehousing procedures” states that: “Written procedures describing the warehousing of drug products shall be ______ and ______.”
5. Match the deviation description to the federal regulations reference number. 483 excerpt: “The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed."
6. Fill in the blanks: According to Subpart J--Records and Reports, 21 CFR 211.194 (d): “Complete records shall be maintained of the ______ ______ of laboratory instruments, apparatus, gauges, and recording devices required by ______.”
  • This question is required
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