Sage Pharmaceuticals Inc – FDA Inspection, Sep 18, 2026

Record Details

This FDA Inspection record concerns Sage Pharmaceuticals Inc, with an inspection on September 18, 2026, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Sage Pharmaceuticals Inc
Inspection Date: September 18, 2026
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Sangeeta M. Khurana (FDA Associated Person)

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ID · b57cf8ec-452a-4871-aa56-8706dfbc78ff

Inspection Facts

Inspection number: 1336186
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.113(a)Procedures for non-sterile drug products
21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
21 CFR 211.22(d)Procedures not in writing, fully followed

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FDA Inspection

Sage Pharmaceuticals IncSeptember 18, 2026