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FDA inspection

Kaken Pharmaceutical Co., Ltd.: FDA inspection ending May 18, 2001

FDA inspection 75791 · Official Action Indicated (OAI) · Fujieda

Key facts

Inspection ID 75791
Firm Kaken Pharmaceutical Co., Ltd.
FEI number 3002807376
Address Kakenseiyaku (Kabu) Shizuokakojo, 301; Gensuke; Gensuke; Gensuke; Gensuke; Gensuke; Gensuke
City Fujieda
Fiscal year 2001
Inspection end date May 18, 2001
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation
Product type Drugs
Warning letter UCM178278

At a glance

  • None 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.

Other inspections at this establishment

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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