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 3010892830.
Observations6
Issue DateAugust 22, 2025
Status2 Related Warning Letters
Establishment TypeSterile Drug Manufacturer
Related Inspections10
Establishment Details
Firm
Nephron SC, LLC
Location
West Columbia, South Carolina, United States
FEI Number
3010892830
Establishment Type
Sterile Drug Manufacturer
Product Type
Drugs
Issue Date
August 22, 2025
Country
United States
Inspection History, 2018 to 2025
NAI2
VAI3
OAI5
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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