The U.S. Food and Drug Administration issued a warning letter to Pfizer Inc.'s Indian manufacturing plant, which is about to be shut down, citing violations of product quality and data integrity issues.
In the March 4 letter, the U.S. regulator said the methods and facilities for manufacturing, processing and packing at Pfizer's manufacturing plant in Irungattukottai, in the state of Tamil Nadu, did not conform to Current Good Manufacturing Practice regulations.
Pfizer had voluntarily paused production at the sterile injectables plant in 2018 after an FDA inspection found issues at the site for the third time since 2013. The issues were related to the manipulation of data by workers was also cited by the FDA.
The FDA said in the warning letter that the New York-based pharmaceutical giants' response to several violations, which included manufacturing and data integrity, was inadequate.
In addition, the U.S. regulator noted that the drug products manufactured at the site were adulterated. The laboratory records did not include complete data derived from all tests, while critical data integrity breaches identified in the inspection raised concerns regarding the validity of all results reported by the quality control laboratory.
The FDA, however, noted that Pfizer had decided to recall all batches of a particular injection set from the U.S. market after testing showed unsatisfactory results.
Earlier in January, Pfizer confirmed its plans to shut down the Irungattukottai plant, which employs about 1,000 people and another facility in Aurangabad in the Indian state of Maharashtra, which employs about 700 people. The company said the decision was taken because manufacturing at these sites was not viable due to significant long-term loss of product demand.
The FDA added in its letter that rectifying the observations will be necessary if Pfizer or an acquirer resumes drug manufacturing at the Irungattukottai facility for the U.S. market.