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 1218996.
Observations9
Issue DateSeptember 27, 2018
StatusNo Warning Letter
Establishment TypeManufacturer
Related Inspections7
Establishment Details
Firm
Magellan Diagnostics, Inc.
Location
North Billerica, Massachusetts, United States
FEI Number
1218996
Establishment Type
Manufacturer
Product Type
Drugs
Issue Date
September 27, 2018
Country
United States
Inspection History, 2011 to 2025
NAI2
VAI3
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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