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 3002911336.
Observations3
Issue DateJuly 23, 2015
StatusNo Warning Letter
Establishment TypeMedical Device Manufacturer
Related Inspections4
Establishment Details
Firm
CooperVisision Manufacturing Puerto Rico LLC
Issued To
Cooper Vision Caribbean
Location
Juana Diaz, Maryland, United States
FEI Number
3002911336
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
July 23, 2015
Country
United States
Inspection History, 2011 to 2014
NAI2
OAI2
NAI means No Action Indicated. OAI means Official Action Indicated.