FDA inspection

Unither Manufacturing LLC.: FDA inspection ending Jan 10, 2020

FDA inspection 1116520 · No Action Indicated (NAI) · Rochester, NY

Key facts

Inspection ID 1116520
Firm Unither Manufacturing LLC.
FEI number 1314625
Address 755 Jefferson Rd
City Rochester
State NY
ZIP 14623-3233
Fiscal year 2020
Inspection end date Jan 10, 2020
Classification No Action Indicated (NAI)
Project area New Drug Evaluation
Product type Drugs

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes 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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