Global Calcium Pvt. Limited — FDA Warning Letter Findings

Failure of your quality unit to prepare, review, and approve documents related to the manufacturing of APIs in accordance with written procedures. You provided production records for two different APIs that showed manufacturing activities occurred simultaneously on the same equipment. For example, your batch records and equipment logbooks show the same equipment including, but not limited to, (b)(4) were used at the same time to manufacture (b)(4) USP and (b)(4) USP…

Failure to properly maintain buildings and facilities used in the manufacture of APIs. You failed to maintain your facility in an acceptable state of repair. For example, investigators observed a room with (b)(4) liquid in a floor cavity surrounding the exit pipe of a (b)(4) . A similar liquid was dripping from a ceiling pipe junction in the (b)(4) area below this room. The liquid was dripping onto processing equipment labeled as clean and ready for use. It is essential your…

Failure to establish an impurity profile for identified and unidentified impurities. You failed to conduct a comprehensive evaluation of your manufacturing processes to identify all potential impurities. For example, the impurity profile you provided for (b)(4) USP, only listed those impurities described in the United States Pharmacopeia (USP), without considering your unique processes and materials to describe additional impurities in a typical lot. Furthermore, you failed…