Published in Medical Letter on the CDC and FDA, November 18th, 2007
The inspection was carried out by Ms. Joy R. Kozlowski-Klena Compliance Officer at the US FDA Center for Drug Evaluation and Research (CDER) and lasted 3 days, starting on October 9th and concluded on the 12th. No form 483 was issued. At the closing meeting, the inspector had several positive comments on our systems and indicated she would be recommending the approval of the site. This inspection covered the TTC's first commercial product - a high potency small molecule API for an injectable formulation. The NDA was filed last May and approval is...
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