Unresolved Manufacturing Facility Deficiencies
Severity: criticalSatisfactory resolution of deficiencies identified during a recent inspection of the manufacturing facility (Ocular Therapeutix, Inc., FEI#3008477155) is required. The methods, facilities, and controls for manufacturing must comply with current good manufacturing practice regulations.
Recommended response: Address all deficiencies identified during the manufacturing facility inspection, ensuring full compliance with cGMP regulations (21 CFR 210 and 211). Provide comprehensive documentation of corrective and preventive actions (CAPA) and evidence of sustained compliance.
Cited: 21 CFR 210, 21 CFR 211
Proprietary Name Resubmission Timing
Severity: minorThe proposed proprietary name DEXTENZA was found acceptable pending approval of the application. The agency requests resubmission of the proposed proprietary name when responding to the application facility inspection-related deficiencies.
Recommended response: Resubmit the proposed proprietary name concurrently with the response to the manufacturing facility deficiencies to ensure proper administrative processing.
Safety Update Required
Severity: majorA comprehensive safety update, as described at 21 CFR 314.50(d)(5)(vi)(b), must be included when responding to the deficiencies. This update should encompass data from all nonclinical and clinical studies/trials of the product, regardless of indication, dosage form, or dose level.
Recommended response: Compile and submit a comprehensive safety update, including all relevant nonclinical and clinical data, in accordance with 21 CFR 314.50(d)(5)(vi)(b) as part of the resubmission.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
Labeling Content Update Required
Severity: majorThe agency reserves comment on the proposed labeling until the application is otherwise adequate. However, any revised labeling must include updated content of labeling as per 21 CFR 314.50(l)(1)(i) in structured product labeling (SPL) format.
Recommended response: Prepare updated content of labeling in SPL format, ensuring compliance with 21 CFR 314.50(l)(1)(i) and relevant guidance, to be submitted once manufacturing issues are resolved.
Cited: 21 CFR 314.50(l)(1)(i)
Additional Manufacturing Control Recommendations
Severity: infoRecommendations include updating visual inspection controls to include acceptable quality limits (AQL) with justification, and providing a comprehensive list of manufacturing, equipment, and procedural changes and controls since the previous resubmission, along with updated batch manufacturing instructions and new production records.
Recommended response: Address these recommendations to strengthen the application's quality control aspects, providing detailed documentation for AQLs and all manufacturing changes, even though they are not immediate approvability issues.
