FDA Inspection
Home Equipment Associates, Inc.Home Equipment Associates, Inc. – FDA Inspection, Apr 5, 2012
Record Details
This FDA Inspection record concerns Home Equipment Associates, Inc., with an inspection on April 5, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 5, 2012
- Product Type
- Drugs
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ID · fa05ea1a-1b9d-4a09-8085-006afa157d9d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 775087
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.22(a)Approve or reject components, products
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