Inspection Record
Inspectors Beatrix D HippeThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
Dmg product production and control records, are not reviewed by the quality control unit to dete1mine compliance with all established, approved written procedures before a batch is released or distributed.
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of diu g products.
Extracted automatically from the document US FDA published on 2026-09-22. 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.
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