1Laboratory and QC controls
Established sampling plan and test procedures are not followed.
Inspection Record
Global Calcium Private Limited — FDA 483 Findings
Inspectors Alan A. RiveraThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
Cleaning procedures are not appropriate or reproducible to prevent contamination that would alter the safety, identity, strength, quality, or purity of the finished drug substances.
3Laboratory 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.
4Laboratory and QC controls
Laboratory controls do not include the estabHshment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform established specificlltions.
5Quality unit oversight
The responsibilities of your Quality Unit are not fully followed A.
About this record
Extracted automatically from the document US FDA published on 2026-04-23. 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.
