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 3012746140.
Observations5
Issue DateNovember 05, 2018
StatusNo Warning Letter
Establishment TypeOutsourcing Facility
Related Inspections2
Establishment Details
Firm
Pentec Health
Location
Upper Chichester, Pennsylvania, United States
FEI Number
3012746140
Establishment Type
Outsourcing Facility
Product Type
Outsourcing Facility
Issue Date
November 05, 2018
Country
United States
Inspection History, 2018 to 2019
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.