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 2027467.
Observations1
Issue DateApril 19, 2017
StatusNo Warning Letter
Establishment TypeMedical Device Manufacturer
Related Inspections8
Establishment Details
Firm
Alphatec Spine, Inc.
Location
Carlsbad, California, United States
FEI Number
2027467
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
April 19, 2017
Country
United States
Inspection History, 2009 to 2022
NAI2
VAI3
OAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.