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 3012144557.
Sharp Sterile Manufacturing, LLC
Lee, Massachusetts, United States
Issue DateJanuary 20, 2023
FEI Number3012144557
CountryUnited States
Status
No Warning Letter
Product Type
Biologics
Establishment Type
Excipient Gel Manufacturer
Sharp Sterile Manufacturing, LLC FDA Form 483, Lee, Massachusetts, January 20, 2023
