Source: FDA, document on fileFDA 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 this against FDA, open FDA's record for this establishment on FDA's Data Dashboard, which lists this inspection under FEI 3012384835.
SKNV
Pompano Beach, Florida, United States
Issue DateSeptember 17, 2018
FEI Number3012384835
CountryUnited States
Status
No Warning Letter
Product Type
Outsourcing Facility
Establishment Type
Outsourcing Facility
Sub Systems Impacted
6
Equipment CleaningInvestigationsMaterial Sampling and TestingProcess ControlSample TestingStability Studies
