1Other quality system
Production records do not contain complete information relating to the production and control of each batch.
Inspection Record
Global Calcium Private Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
An on-going testing program to monitor the stability characteristics ofAPIs is not established and followed.
3Equipment and facility
Facility and equipment are not maintained in a manner that prevents contamination of APIs by other materials.
4Other quality system
Established impurity profiles for US market APIs are inadequate.
5Documentation and records
Deviations from established procedures were not documented in batch records and investigated.
6Other quality system
Procedures for issuance and controls of documents are not followed.
About this record
Extracted automatically from the document US FDA published on 2024-08-28. 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.
