FDA inspection

Balassa Laboratories, Inc: FDA inspection ending Feb 19, 2013

FDA inspection 819218 · Official Action Indicated (OAI) · Port Orange, FL

Key facts

Inspection ID 819218
Firm Balassa Laboratories, Inc
FEI number 1050280
Address 509 Herbert St Ste A
City Port Orange
State FL
ZIP 32129
Country United States
Fiscal year 2013
Inspection end date Feb 19, 2013
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • 10–99 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No 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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