Hema Diagnostic Systems, L.L.C.

Form 483

Miramar, Florida, United StatesFEI 3003567343Issued December 10, 2014

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 3003567343.

Observations4

Issue DateDecember 10, 2014

StatusNo Warning Letter

Related Inspections2

Establishment Details

Firm: Hema Diagnostic Systems, L.L.C.
Location: Miramar, Florida, United States
FEI Number: 3003567343
Product Type: Devices
Issue Date: December 10, 2014
Country: United States

Inspection History, 2013 to 2014

VAI1

OAI1

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.

Hema Diagnostic Systems, L.L.C. FDA Form 483, Miramar, Florida, December 10, 2014