FDA Inspection
Lead Chemical Co., Ltd.Lead Chemical Co., Ltd. – FDA Inspection, Aug 28, 2015
Record Details
This FDA Inspection record concerns Lead Chemical Co., Ltd., with an inspection on August 28, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lead Chemical Co., Ltd.
- Inspection Date
- August 28, 2015
- Product Type
- Drugs
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ID · 8fe0e1cb-9104-4fb4-b63b-955c99563914
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 942540
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(a)Lab controls established, including changes
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Other FDA inspections of Lead Chemical Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| August 3, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 7, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lead Chemical Co., Ltd.
- FDA Inspection 1276525 - 2025-07-24
- FDA Inspection 1065632 - 2018-08-03
- FDA Inspection 855690 - 2013-09-20
- FDA Inspection 746790 - 2011-09-07
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