Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3006575795.
Observations8
Issue DateAugust 11, 2016
Status1 Related Warning Letter
Related Inspections7
Establishment Details
Firm
Zyno Medical LLC
Location
Natick, Massachusetts, United States
FEI Number
3006575795
Product Type
Devices
Issue Date
August 11, 2016
Country
United States
Inspection History, 2008 to 2025
NAI1
VAI3
OAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.