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Warning letter issued to Hospira, India Facility

Updated: 04 March 2019

Data integrity issues along with cGMP violations in Hospira, India facility leads them to receive a warning letter by FDA Dated 04 March 2019. FDA inspected the Tamil Nadu's Hospira facility from 27 March to 03 April 2018. Several cGMP violations have been observed during the inspection ranging from data integrity issues to unacceptable batch failure investigations.

Test results were not appropriately reported in the microbiology laboratory of Hospira facility. FDA stated that "During the inspection, your staff confirmed that laboratory records did not accurately reflect the actual microbial growth observed on plates,". A report has been requested by the company regarding corrective actions and preventive actions in order to ensure that all the aseptic operations have been maintained along with complete requalification of personnel accountable to perform these operations, retrospective review regarding the laboratory data's reliability and enhancement variations to quality control laboratories.

Adequate investigation was not performed regarding critical defects observed in manufacturing procedures. As per the letter "The extent of these critical drug quality defects was further revealed when examination of reserve samples identified many (b)(4) appearance defects, although the lots had undergone the required 100% visual inspection and had met AQL[acceptable quality limit] sampling criteria".

A report has been requested on process improvements, design evaluation and state of cycle control which has been utilized to manufacture drug products especially for United States. If the company wants to resume drug manufacturing activities at Hospira, Tamil Nadu for US market, then they need to remediate all the cGMP violations.