Inspection Record
Inspectors Ronda R Loyd JonesThe inspectors who signed the published document.Inspector lookup
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Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assume that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Written records are not always made of investigations into unexplained discrepancies.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
Extracted automatically from the document US FDA published on 2026-09-29. 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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