FDA inspection

Buderer Drug Company Inc: FDA inspection ending Jan 4, 2016

FDA inspection 959244 · Official Action Indicated (OAI) · Perrysburg, OH

Key facts

Inspection ID 959244
Firm Buderer Drug Company Inc
FEI number 3005664940
Address 26611 Dixie Hwy Ste 119
City Perrysburg
State OH
ZIP 43551
Country United States
Fiscal year 2016
Inspection end date Jan 4, 2016
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs
Warning letter 506509

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes Warning letter followed
  • Yes Form FDA 483 issued
  • Yes Establishment inspection report (EIR) exists
  • 1–9 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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