1Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Inspection Record
Wizcure Pharmaa Private Limited — FDA 483 Findings
Inspectors Lisa L. FloresThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
3Process validation
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
4Equipment and facility
Equipment and utensils are not cleaned or maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
7Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed.
About this record
Extracted automatically from the document US FDA published on 2026-07-27. 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.
