FDA Inspection
CONCORD BIOTECH LIMITEDCONCORD BIOTECH LIMITED – FDA Inspection, Jul 21, 2017
Record Details
This FDA Inspection record concerns CONCORD BIOTECH LIMITED, with an inspection on July 21, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 8ec510d1-21f5-4884-926d-4a031a653b49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021293
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.84(c)(4)Compositing of Sub Samples
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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 |
| 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 |
Other documents for CONCORD BIOTECH LIMITED
- FDA Inspection 1200525 - 2023-03-17
- FDA Inspection 1069171 - 2018-10-18
- FDA Inspection 1046571 - 2018-02-16
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