FDA Inspection
QUALITY AIR PRODUCTS INCQUALITY AIR PRODUCTS INC – FDA Inspection, Sep 16, 2010
Record Details
This FDA Inspection record concerns QUALITY AIR PRODUCTS INC, with an inspection on September 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- QUALITY AIR PRODUCTS INC
- Inspection Date
- September 16, 2010
- Product Type
- Drugs
View Company Profile
ID · 3a3430e5-553a-4038-8f55-022ec7f40825
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680342
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(a)Accurate reproduction included
- 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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