FDA inspection

Sharp Sterile Manufacuring, LLC: FDA inspection ending Oct 21, 2024

FDA inspection 1254740 · Official Action Indicated (OAI) · Lee, MA

Key facts

Inspection ID 1254740
Firm Sharp Sterile Manufacuring, LLC
FEI number 3012144557
Address 480 Pleasant St
City Lee
State MA
ZIP 01238-9265
Fiscal year 2025
Inspection end date Oct 21, 2024
Classification Official Action Indicated (OAI)
Project area New Drug Evaluation
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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