Sofgen Pharmaceuticals LLC

Form 483

Issued to: Sancilio & Company, Inc.

Riviera Beach, Florida, United StatesFEI 2000027140Issued May 16, 2017

View Form 483 PDF

Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 2000027140.

Observations8

Issue DateMay 16, 2017

StatusNo Warning Letter

Establishment TypeDrug Manufacturer

Related Inspections0

Establishment Details

Firm: Sofgen Pharmaceuticals LLC
Issued To: Sancilio & Company, Inc.
Location: Riviera Beach, Florida, United States
FEI Number: 2000027140
Establishment Type: Drug Manufacturer
Product Type: Drugs
Issue Date: May 16, 2017
Country: United States

Inspection History

We hold no FDA inspection matched to this establishment.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Sofgen Pharmaceuticals LLC FDA Form 483, Riviera Beach, Florida, May 16, 2017