FDA Inspection
Bioelements Inc.Bioelements Inc. – FDA Inspection, Oct 27, 2021
Record Details
This FDA Inspection record concerns Bioelements Inc., with an inspection on October 27, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bioelements Inc.
- Inspection Date
- October 27, 2021
- Product Type
- Drugs
View Company Profile
ID · 863a56d2-8a03-4146-bf20-6f2d705656f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1155328
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(6)Comparison of Test Results to Specifications
- 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 Bioelements Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2017 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| September 6, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 11, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bioelements Inc.
- FDA Inspection 1007571 - 2017-02-10
- FDA Inspection 797685 - 2012-09-06
- FDA Inspection 645568 - 2010-02-11
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