Pharmaceutical & biotech regulatory ontology
Connect regulations, guidance, inspections, legislation and more to see the context.
An FDA warning letter cites a specific regulation. Follow that citation to the source. Check the citation, then read the wording. Here, the letter cites 21 CFR 211.113(b). Compare the finding with the referenced wording. Open the warning letter in MapRegula to explore its cited sources.
One connection, with the original wording
We bring together regulations, guidance, inspection findings, legislation and other sources to reveal the relationships between documents and the context you need for review.
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Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).Reliance Life Sciences Private Limited
Read the FDA warning letter ↗(b) Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of all aseptic and sterilization processes.Control of microbiological contamination
Read the regulation on eCFR ↗Choose 21 CFR 211.113 to read the passages side by side.
The collection is growing; coverage varies by source. EMA coverage and regulatory change alerts are planned.
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