FDA Inspection
CONCORD BIOTECH LIMITEDCONCORD BIOTECH LIMITED – FDA Inspection, Oct 18, 2018
Record Details
This FDA Inspection record concerns CONCORD BIOTECH LIMITED, with an inspection on October 18, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · e95feb8e-3174-44bd-accb-f938e253778b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069171
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.160(a)Deviations from laboratory control requirements
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Other FDA inspections of CONCORD BIOTECH LIMITED
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1200525 - 2023-03-17
- FDA Inspection 1046571 - 2018-02-16
- FDA Inspection 1021293 - 2017-07-21
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