Strata Skin Sciences, Inc.

Form 483

Issued to: PhotoMedex, Inc.

Carlsbad, California, United StatesFEI 3002942014Issued July 22, 2015

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 3002942014.

Observations6

Issue DateJuly 22, 2015

StatusNo Warning Letter

Establishment TypeMedical Device Manufacturer

Related Inspections9

Establishment Details

Firm: Strata Skin Sciences, Inc.
Issued To: PhotoMedex, Inc.
Location: Carlsbad, California, United States
FEI Number: 3002942014
Establishment Type: Medical Device Manufacturer
Product Type: Devices
Issue Date: July 22, 2015
Country: United States

Inspection History, 2009 to 2024

NAI2

VAI7

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.

Strata Skin Sciences, Inc. FDA Form 483, Carlsbad, California, July 22, 2015