1Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not always include the conclusion and follow- up.
Inspection Record
A. Nelson & Co. Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
Complaint investigations under Quality Unit oversight are inadequate.
3Process validation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
4Quality unit oversight
Document control procedures under Quality Unit oversight are inadequate.
About this record
Extracted automatically from the document US FDA published on 2026-07-21. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
