Inspection Record
Inspectors Anna M Spiros · Jordan S Burkdoll · Logan T WilliamsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
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.
Employees engaged in the processing of a drug product lack the training required co perfonn their assigned functions.
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of processing of the drug product.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Extracted automatically from the document US FDA published on 2026-01-22. 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.
Growth stages previewSolve a quiz to start hatching
Your growth record is stored safely in this browser.
