FDA Inspection
Dead Sea Bromine Company Ltd.Dead Sea Bromine Company Ltd. – FDA Inspection, Jul 18, 2019
Record Details
This FDA Inspection record concerns Dead Sea Bromine Company Ltd., with an inspection on July 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Walden H. Lee (FDA Associated Person)
- Yvesna C. Blaise (Issuing Officer)
View Company Profile
ID · 637ddef6-8271-469d-ab23-4e0634ed7296
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097015
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
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Other FDA inspections of Dead Sea Bromine Company Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dead Sea Bromine Company Ltd.
- FDA Inspection 933492 - 2015-06-25
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