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 3012144557.
Observations6
Issue DateMarch 05, 2026
StatusNo Warning Letter
Related Inspections6
Establishment Details
Firm
Sharp Sterile Manufacturing, LLC
Location
Lee, Massachusetts
FEI Number
3012144557
Product Type
Drugs
Issue Date
March 05, 2026
Country
United States
Inspection History, 2020 to 2026
VAI4
OAI2
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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