FDA Classified its 2017 inspection as OAI ("Official Action Indicated").
OCUL plant was BLOCKED from approvals heading into July 19 PDUFA.
1) If the FDA made the classification before the PDUFA, the site was blocked, and management should have disclosed this material piece of news
2) If the FDA made the classification after the PDUFA, the company should have disclosed their expectation of a CRL, since they hadn't responded to the 483 observations prior to the PDUFA
Firm NameStreet AddressCityStateZipCountryInspection DateInsp Classification
Ocular Therapeutix Inc.36 Crosby Dr Ste 101BedfordMA01730-1402United States5/4/2017OAI