Stason Pharmaceuticals, Inc.

Form 483FOIA Uncovered

Irvine, California, United StatesFEI 1000160561Issued April 13, 2021

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1000160561.

Observations2

Issue DateApril 13, 2021

Status1 Related Warning Letter

Related Inspections10

Establishment Details

Firm: Stason Pharmaceuticals, Inc.
Location: Irvine, California, United States
FEI Number: 1000160561
Product Type: Drugs
Issue Date: April 13, 2021
Country: United States

Inspection History, 2010 to 2021

NAI3

VAI6

OAI1

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

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.

Stason Pharmaceuticals, Inc. FDA Form 483, Irvine, California, April 13, 2021