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An experimental eye drug from Ocular Therapeutix, already rejected once by the FDA, could this month be turned away a second time because of product contamination, including aluminum, found by an FDA inspector during a visit to the company’s manufacturing facility.

Ocular disclosed the receipt of the FDA manufacturing warning letter — known in regulatory parlance as a Form 483 — on its quarterly conference call held May 5. Ocular executives reassured investors and analysts on the call that the issues raised by FDA were easily fixed because they related more to inspection procedures and employee training.

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  • As Joseph Busfield correctly points out, an FDA 483 is different from an FDA Warning Letter. The FDA issues a 483 first, usually around the time or shortly after they inspect a facility. It cites deficiencies etc. The company has an alloted period of time to respond to the FDA and provide a plan to correct the deficiencies.

    If/when the co. fails to adequately respond to FDA observations in the 483, then the FDA would issue a Warning Letter. So, an FDA Warning Letter is usually more serious because the company has been unable to fully address FDA concerns. An FDA Warning Letter is also a public document that is (eventually) posted on the FDA website.

    Please clarify and if necessary, correct your post to accurately reflect the FDA document cited in your post.

  • If you really have the most recent 483 (which hasn’t been made public) then you should post that to validate your claims. Otherwise what you’re saying is speculation at best, which is morally questionable…Talmo took another job with J&J which is a much larger company that OCUL the last time I checked

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