FDA warning letter for troubled Wockhardt plant
pharmafile | July 23, 2013 | News story | Manufacturing and Production |Â Â FDA, Wockhardt, warningÂ
The US regulator has issued a warning letter to a facility operated by Indian drugmaker Wockhardt already subject to an import ban in the US and Europe.
The warning letter has not yet been posted on the FDA website, but Wockhardt confirmed it had been received in a filing to India’s National Stock Exchange (NSE) which prompted a 9% fall in its share price.
The statement confirmed that the Waluj facility in Aurangabad – which has been subject to import bans imposed by both the FDA and the UK Medicines & Healthcare products Regulatory Agency (MHRA) – was the subject of the warning letter which “lists the observations made during [an earlier] inspection”.
“The company has already initiated several corrective actions to resolve the same,” said Wockhardt, adding: “Our earlier clarification on the implications of the import alert on the company’s consolidated revenues for the current financial year remains unchanged.”
Production at the plant has been temporarily suspended and Wockhardt has said it should be able to maintain supplies of the affected products from other GMP-certified sites, at least in Europe, limiting the impact of the import alert to around $100 million for the year.
Some analysts believe that is an optimistic appraisal, particularly as around half of Wockhardt’s pending Abbreviated New Drug Applications (ANDA) in the US cite the Waluj facility as their manufacturing location. As of 31 March, the number of products awaiting approval by the FDA stood at 46.
Meanwhile, under US rules approval will have to be sought to ship product from other locations, and Abhishek Singhal of Macquarie Research told the Business Standard newspaper that Wockhardt’s liability could reach $135 million. In its last financial year Wockhardt sales passed the $1 billion mark for the first time.
The MHRA also ordered a recall of a number of Wockhardt medicines made at Waluj, noting that the deficiencies at the plant included a risk of cross-contamination because of poor cleaning practices and defects in building fabric and the ventilation systems at the site. There was also evidence of forged documents relating to staff training records that had been rewritten. The loss from the recall has been estimated at around £1.5 million ($2.3m).
The facility failed a US inspection earlier this year and was issued with a Form 483 citing a number of deficiencies in April in production areas handling injectable products. It was also taken to task by the FDA in 2006 and issued a warning letter over poor record-keeping.
Phil Taylor
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