FDA Inspection
CONCORD BIOTECH LIMITEDCONCORD BIOTECH LIMITED – FDA Inspection, Mar 17, 2023
Record Details
This FDA Inspection record concerns CONCORD BIOTECH LIMITED, with an inspection on March 17, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 24dd5fd7-bc4a-49c5-a1bd-3cea113e9b35
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1200525
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of CONCORD BIOTECH LIMITED
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2018 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| February 16, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2017 | VAI | Office of Inspections and Investigations | New Drug Evaluation |
Other documents for CONCORD BIOTECH LIMITED
- FDA Inspection 1069171 - 2018-10-18
- FDA Inspection 1046571 - 2018-02-16
- FDA Inspection 1021293 - 2017-07-21
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