FDA Inspection
A. Nelson & Co., Ltd.A. Nelson & Co., Ltd. – FDA Inspection, Jan 29, 2016
Record Details
This FDA Inspection record concerns A. Nelson & Co., Ltd., with an inspection on January 29, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- A. Nelson & Co., Ltd.
- Inspection Date
- January 29, 2016
- Product Type
- Drugs
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ID · 6add20bc-40df-4b64-a48d-8faed3a7c574
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955743
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.198(a)Quality Control Review
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(1)Samples (various types) representative, identified properly
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of A. Nelson & Co., Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2025 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 20, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 21, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 14, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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- FDA Inspection 1060680 - 2018-06-20
- FDA Inspection 1057098 - 2017-04-21
- FDA Inspection 754554 - 2011-11-14
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