Actelion Pharmaceuticals US Inc. – FDA Inspection, Oct 28, 2024

Record Details

This FDA Inspection record concerns Actelion Pharmaceuticals US Inc., with an inspection on October 28, 2024, issued by the New Jersey District Office, covering human drugs.

Company: Actelion Pharmaceuticals US Inc.
Inspection Date: October 28, 2024
Product Type: Human Drugs
Office: New Jersey District Office
People: Tyanna N. Hadley (Company Rep)
Vanessa E. Coulter (Issuing Officer)

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ID · 42933576-b78e-47aa-9776-8c1f99b939b9

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1252745
FDA center: Human Drugs
Project area: Postmarketing Surveillance and Epidemiology: Human Drugs
Outcome: Form 483 issued

FDA Citations

Failure to comply with REMS Implementation System
Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
FDCA 505-1(f)(3)(B)Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
FDCA 505-1(f)(4)Failure to comply with REMS Implementation System

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FDA Inspection

Actelion Pharmaceuticals US Inc.October 28, 2024