FDA Inspection
TAIWAN BIOTECH CO., LTD.TAIWAN BIOTECH CO., LTD. – FDA Inspection, Sep 11, 2017
Record Details
This FDA Inspection record concerns TAIWAN BIOTECH CO., LTD., with an inspection on September 11, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Ileana Barreto-Pettit (Issuing Officer)
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ID · b3d1b982-35e3-4c9d-b153-18cecd5f1744
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1026548
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.180(e)(1)Representative Number of Batches for Annual Review
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of TAIWAN BIOTECH CO., LTD.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 18, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 2, 2016 | Not classified | Office of Inspections and Investigations | |
| May 30, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 26, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for TAIWAN BIOTECH CO., LTD.
- FDA Inspection 1181337 - 2022-09-20
- FDA Inspection 1014787 - 2017-05-18
- FDA Inspection 1042234 - 2016-12-02
- FDA Inspection 885228 - 2014-05-30
- FDA Inspection 746051 - 2011-08-26
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