Global Calcium India Facility Hit with FDA-483

An FDA inspection earlier this month of a Global Calcium manufacturing facility in Hosur, India has resulted in a six-observation Form FDA-483 that cites significant GMP violations. For example, the agency investigators said the firm’s production records do not contain complete information relating to the production and control of each batch. The document says employees created batch records, cleaning records and equipment use logs for activities that did not occur.

The investigators also found that the firm’s on-going stability testing program for manufactured active pharmaceutical ingredients (APIs)  is not established and followed. Additionally, the cited the facility for not maintaining the facility and equipment in a manner that prevents contamination of APIs by other materials, and for not documenting deviations from procedures in the batch records or investigating them.