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 3003098680.
Observations1
Issue DateApril 18, 2024
StatusNo Warning Letter
Establishment TypeBiologics & Medical Device Manufacturer
Talk to a Specialist