FDA Warning Letter — Pentax of America Inc

Case 392291 — FEI 1000080301

The FDA took a Warning Letter action against Pentax of America Inc on March 29, 2013 (Montvale, NJ). The action was issued by CDRH and concerns devices products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
Pentax of America Inc
Date
March 29, 2013
Fiscal Year
2013
Product Type
Devices
Center
CDRH
Location
Montvale, NJ (United States)