Inspection Record
Inspectors Sean R MarcsisinThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
The number of qualified personnel is inadequate to perform the manufacture of each drug product.
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a diug product.
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size to facilitate cleaning, maintenance, and proper operations.
Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile are not established, written and followed.
Extracted automatically from the document US FDA published on 2025-09-18. 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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