FDA Inspection
Sky Systems Co., Inc.Sky Systems Co., Inc. – FDA Inspection, Sep 30, 2020
Record Details
This FDA Inspection record concerns Sky Systems Co., Inc., with an inspection on September 30, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sky Systems Co., Inc.
- Inspection Date
- September 30, 2020
- Product Type
- Drugs
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ID · 38f85c09-ae92-4645-99be-c44a50fd293e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1130482
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
Showing 10 of 12 citations.
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Other FDA inspections of Sky Systems Co., Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2017 | 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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