Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
Inspection Record
Perrigo New York, Inc. — FDA 483 Findings
Inspectors Edmund F MrakThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.
About this record
Extracted automatically from the document US FDA published on 2026-10-19. 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.
