1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
Inspection Record
The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories — FDA 483 Findings
Inspectors Demario L Walls · Nelson N Ayangho · Sarah E VentiThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy anda failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
3Other quality system
Your firm failed to have systems in place to enable compliance with the verification requirements ofthe DSCSA.
About this record
Extracted automatically from the document US FDA published on 2026-07-28. 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.
