FDA Warns Jubilant, Pfizer Subsidiary in India

Regulatory NewsRegulatory News | 13 March 2019 |  By 

The US Food and Drug Administration (FDA) last week sent warning letters to Pfizer’s subsidiary Hospira and Jubilant Life Sciences over good manufacturing practice (GMP) violations at the companies’ facilities in India.
In its warning letter to Pfizer, FDA says that products made at its Hospira facility in Tamil Nadu, India are adulterated as a result of data integrity breaches and laboratory testing shortcomings observed during a week-long inspection last spring.
According to FDA, Hospira’s microbiology lab did not accurately report microbial growth test results. On the first day of the inspection, FDA says its investigator found microbial growth on multiple personnel and environmental monitoring media plates.
“However, our review of laboratory records found that analysts had recorded a result of ‘nil’ (no growth) for each of these plates. On the same day, our investigator also observed that your microbiologist had significantly underreported microbial results for three [redacted] samples,” FDA writes.
FDA also says the company failed to thoroughly investigate “poor control and critical defects” in one of its manufacturing processes.
While the citation redacts many of the details regarding the defects and manufacturing process, FDA says that Hospira’s investigations “did not sufficiently determine the root cause of recurring batches with significant [redacted] defects when no power interruptions and cycle deviations were documented.”
During the inspection, FDA also requested that Hospira retest multiple batches of its products that were all reported as passing by the company. Each batch was found to be out-of-specification during retesting.
Shortly after the inspection, Pfizer stopped production at the facility before permanently closing the site earlier this year.
FDA notes the facility’s closure in the warning letter, adding that the agency “acknowledge[s] your commitment for third-party consultants to continue performing product quality assessments, including ongoing review of adverse events and customer complaints for drugs remaining in distribution for this facility.”
FDA also adds that Pfizer or any successor that plans to reopen the facility to manufacture products for the US market will need to address the GMP issues cited in the letter before resuming distribution to the US.
Jubilant Life Sciences
FDA’s warning letter to Jubilant Life Sciences comes after a week-long inspection last summer that found the company did not adequately investigate product deviations and customer complaints related to two of its products, including valsartan and pantoprazole.
According to FDA, the company did not “adequately justify root causes, expand investigations into all potentially affected batches, implement corrective and preventative actions (CAPA) in a timely manner, or evaluate CAPA effectiveness.”
In one instance, Jubilant identified a particle size issue for an excipient used in manufacturing valsartan. Despite expanding its investigation and identifying 12 batches of valsartan intended for the US market made using that excipient, the firm only recalled two of the batches prior to the inspection. The remaining ten batches were recalled the week after the inspection.
FDA also cites the company for selectively testing samples of its pantoprazole delayed release tablets after receiving multiple complaints that the tablets were “rippled,” “wet” and “discolored.” FDA says the company only tested samples with minor defects and neglected to perform dissolution testing on tablets that were more likely to fail.
Warning Letters: Pfizer, Jubilant


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