FDA Inspection
Sky Systems Co., Inc.Sky Systems Co., Inc. – FDA Inspection, Mar 2, 2017
Record Details
This FDA Inspection record concerns Sky Systems Co., Inc., with an inspection on March 2, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ae46045b-4f5b-45d2-8946-a3e47c934220
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010515
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.80(d)Identification of Each Lot in Each Shipment
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.111Establishment of time limitations
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Other FDA inspections of Sky Systems Co., Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 24, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 17, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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