FDA Inspection
DS Healthcare Group, Inc.DS Healthcare Group, Inc. – FDA Inspection, Mar 29, 2018
Record Details
This FDA Inspection record concerns DS Healthcare Group, Inc., with an inspection on March 29, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5285403f-2f07-495d-9439-6160d4798772
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046109
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
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