1Laboratory and QC controls
Samples taken of drug products for determination of conformance to written specifications are not representative.
Inspection Record
Hikma Injectables USA Inc. — FDA 483 Findings
Inspectors Edmund F Mrak · Ogechi C Nna · Luxuly AbrahamThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
About this record
Extracted automatically from the document US FDA published on 2024-07-26. 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.
