Inspection Record
Inspectors Justin A Boyd · Darren S BrownThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
fuvestigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same diu g product and other di11g products that may have been associated with the specific failure or discrepancy.
The written stability testing program is not followed.
Batch production and control records do not include complete info1mation relating to the production and control of each batch.
Appropriate controls ai·e not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Equipment used in the manufacture, processing, packing or holding of dmg products is not of appropriate design to facilitate operations for its intended use.
Extracted automatically from the document US FDA published on 2022-05-24. 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.
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