FDA Inspection
Coating Systems Laboratories, IncCoating Systems Laboratories, Inc – FDA Inspection, Aug 2, 2016
Record Details
This FDA Inspection record concerns Coating Systems Laboratories, Inc, with an inspection on August 2, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 2, 2016
- Product Type
- Drugs
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ID · 1bf3287b-529a-4f92-92f1-9efe7d56356f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983913
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Coating Systems Laboratories, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 26, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Coating Systems Laboratories, Inc
- FDA Inspection 710074 - 2011-02-11
- FDA Inspection 649294 - 2010-02-26
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