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 3007594734.
Observations7
Issue DateMay 30, 2019
Status1 Related Warning Letter
Related Inspections3
Establishment Details
Firm
CellEra LLC
Location
Monroe, Ohio, United States
FEI Number
3007594734
Product Type
Devices
Issue Date
May 30, 2019
Country
United States
Inspection History, 2019 to 2022
VAI2
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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