Global Calcium Pvt. Limited – FDA 483, Aug 2, 2024

This FDA Form 483 details significant violations at a facility manufacturing API for the US market, specifically "8047 Injection Grade API."

**Observation #1** highlights that production records lack complete and accurate information. The Production Head and Plant 8047 Manager admitted to directing employees to fabricate batch records, cleaning records, and equipment use logs for activities that did not occur, using Microsoft Excel plans. These plans were deleted by the Production Head during the inspection. Review of records for released US market product revealed numerous conflicts, including duplicate records for the same equipment and time, documenting different batches. For example, batch records for "Injection API batch" and "batch" showed conflicting use of the same equipment.

**Observation #2** indicates that procedures for document issuance and control are not followed. QA issued duplicate equipment and cleaning logs with the same issuance numbers, which were used to create contradictory records that QA subsequently approved. Additionally, the QC laboratory maintained uncontrolled notebooks for measurements, with employees transcribing data into controlled reports.

**Observation #3** states that an ongoing stability testing program for APIs is not established or followed. Multiple stability samples for various batches, including those for US market product, could not be located or lacked proper protocols, packaging, or storage conditions. Some required time points were missing, and there were no records of sample transfers between stability chambers. Furthermore, methods for stability testing of "Redacted injection USP" were not shown to be stability indicating.