CryoGam Colorado, LLC.

Form 483

Loveland, Colorado, United StatesFEI 3004092640Issued July 28, 2017

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 3004092640.

Observations2

Issue DateJuly 28, 2017

StatusNo Warning Letter

Related Inspections7

Establishment Details

Firm: CryoGam Colorado, LLC.
Location: Loveland, Colorado, United States
FEI Number: 3004092640
Product Type: Biologics
Issue Date: July 28, 2017
Country: United States

Inspection History, 2008 to 2025

NAI5

VAI2

NAI means No Action Indicated. VAI means Voluntary 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.

CryoGam Colorado, LLC. FDA Form 483, Loveland, Colorado, July 28, 2017