FDA issues warning letters to Pfizer’s site in south India and Jubilant Generics

By PharmaCompass

2019-03-14

Impressions: 123 Article

In early January, Pfizer announced that two manufacturing sites in India, which it had acquired through its US$ 17 billion acquisition of Hospira, will cease manufacturing operations. The sites located near Chennai (Irungattukottai) and Aurangabad employ 1,700 people.

This week, FDA posted a warning letter for the operations at the Irungattukottai site as it found during its March 2018 inspection that the site’s microbiology laboratory did not accurately report test results.

During a walk-through of the laboratory, the FDA investigator observed microbial growth on personnel/environmental monitoring media plates. However, when the laboratory records were reviewed, the analysts had recorded a result of “Nil” (no growth) for each of the plates. The investigator also observed other instances where a microbiologist significantly underreported sample results.

The situation repeated itself in the case of a batch of finished product, which was initially tested and released but failed on retesting in the presence of the investigators.

Consistent with the recent FDA observations at other sites, Pfizer’s operations were also cited for inadequate investigations into manufacturing process defects.

The Irungattukottai site had received an FDA warning letter in 2013 and in 2016. Pfizer halted production at the plant after a PIC/S (short for Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) joint inspection with regulators from four international agencies, MHRA (Medicines and Healthcare products Regulatory Agency of the UK), USFDA (United States Food and Drug Administration), TGA (Therapeutic Goods Administration of Australia) and Health Canada, found various quality control problems.

A Pfizer spokesperson had then told The Economic Times: “A holistic plan is being developed to address specific inspection observations and to implement enhancements to site operations.”

FDA issued a warning letter to another Indian company — Jubilant Generics Limited. The warning letter was issued to Jubilant’s finished dosage form manufacturing operations in Roorkee, as it found that the company’s investigations into deviations and consumer complaints were inadequate.

In one case, the firm identified a problem with a batch of crospovidone excipient, which by Jubilant’s own assessment impacted 12 batches of valsartan tablets that had been shipped to the US market. The warning letter raised concern as Jubilant recalled only two batches but failed to recall the remaining 10 batches from the market.

The FDA also highlighted shortcomings in Jubilant’s quality control change management procedures and stated that the violations observed were a repeat from a 2016 inspection where FDA had cited similar concerns.

Jubilant’s site at Roorkee in India was inspected by the FDA from July 30, 2018 to August 8, 2018.

This week, the FDA also issued a warning letter to an OTC drug manufacturer in India — Anicare Pharmaceutical Private Limited — and placed Centurion Pharmaceuticals on import alert.

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