FDA Warning Letter — OraWell USA

Case 218975 — FEI 3008996355

The FDA took a Warning Letter action against OraWell USA on September 21, 2011 (Philadelphia, PA). The action was issued by CBER and concerns biologics products. This facility has 2 recent FDA inspections on record.

Action Details

Facility
OraWell USA
Date
September 21, 2011
Fiscal Year
2011
Product Type
Biologics
Center
CBER
Location
Philadelphia, PA (United States)