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FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.
FDA sent a warning letter, dated March 4, 2019, to Worldwide Pfizer after an inspection of the company’s Hospira Healthcare India Pvt. Ltd. in Tamil Nadu, India, discovered current good manufacturing violations that ranged from data integrity problems to unsatisfactory investigation of batch failures. The investigation was performed from March 27–April 3, 2018.
The Hospira facility’s microbiology laboratory did not accurately report test results, according to the agency. “During the inspection, your staff confirmed that laboratory records did not accurately reflect the actual microbial growth observed on plates,” the letter stated. The agency requested the company provide a report on corrective actions and preventive actions (CAPA) “to assure that aseptic processing operations are maintained in a state of control, including fully requalifying personnel involved in these operations”; a report on enhancement changes to quality control laboratories; and a retrospective review of reliability of all microbiology laboratory data.
FDA also stated that poor control and critical defects in manufacturing processes were not adequately investigated. “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,” the letter stated.
The agency requested the company provide a report on process improvements; an evaluation of the design and state of control of cycles used to produce drug products for the United States; and a CAPA for “routine, vigilant operations management oversight of facilities and equipment to assure prompt detection of equipment performance issues, execution of repairs, completion of preventive maintenance, upgrades to equipment and facilities, and other appropriate actions.”
According to the warning letter, the company decided to cease all production and distribution of drug products from the facility; however, FDA stated that “remediating these CGMP violations will be necessary if Pfizer, a successor, or an acquirer resumes drug manufacturing operations at this site for the US market.” FDA placed the facility on Import Alert 66-40 on August 1, 2018.