In a letter to Taro managing director Barrie Levitt, the US Food and Drug Administration (FDA) said that testing in place at the Brampton plant is “inadequate to assess the stability characteristics of drug products,” citing betamethasone valerate, fluocinonide and ciclopirox among those that were outside specifications.
The agency also criticised Taro QA measures, commenting that: “out-of specification results or unexplained discrepancies were neither thoroughly investigated nor performed in a timely manner.”
The FDA said that Taro should take prompt action to correct all the violations that had been observed and added that it “will recommend disapproval of any new applications or supplements listing your firm as a manufacturing location of finished dosage forms and active pharmaceutical ingredients until all corrections have been completed.”
Taro said that the warning letter is the first that it, or any of its affiliates, have received and added that it intends to issue a full response within 30 days.
Taro is currently involved in a lawsuit against Sun Pharmaceuticals, in a bid to prevent a takeover by the latter firm. The two companies had signed a $454m merger agreement in May 2007, which Taro backed out of a year later.
At present Taro is appealing a ruling by a Tel Aviv district court that branded the firm "disingenuous" claiming that Sun had been required to submit a “special tender offer” to proceed with the acquisition under Israeli law.