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FDA Inspection
•Evofem Biosciences Inc.•September 11, 2026

Evofem Biosciences Inc. – FDA Inspection, Sep 11, 2026

Record Details

This FDA Inspection record concerns Evofem Biosciences Inc., with an inspection on September 11, 2026, issued by the Los Angeles District Office, covering human drugs.

Company
Evofem Biosciences Inc.
Inspection Date
September 11, 2026
Product Type
Human Drugs
Office
Los Angeles District Office
Person
  • Jose A. Leyva (Issuing Officer)
View Company Profile

ID · 26179937-7cf2-4719-ad64-c79c76cdc38d

Inspection Facts

Inspection number
1300796
FDA center
Human Drugs
Project area
Postmarket Surv. and Epidemiology
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
  2. 21 CFR 314.81(b)(2)Timely submission

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Evofem Biosciences Inc.

2
DateClassificationOfficeProject area
August 28, 2015NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
November 28, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Evofem Biosciences Inc.
  • FDA Inspection 940944 - 2015-08-28
  • FDA Inspection 808507 - 2012-11-28

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