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 3008563008.
Observations6
Issue DateSeptember 28, 2017
Status2 Related Warning Letters
Establishment TypeOutsourcing Facility
Related Inspections10
Establishment Details
Firm
Exela Pharma Sciences LLC
Location
Lenoir, North Carolina, United States
FEI Number
3008563008
Establishment Type
Outsourcing Facility
Product Type
Outsourcing Facility
Issue Date
September 28, 2017
Country
United States
Inspection History, 2012 to 2024
NAI6
VAI3
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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