FDA Inspection
Diamond Respiratory Care IncDiamond Respiratory Care Inc – FDA Inspection, Nov 18, 2014
Record Details
This FDA Inspection record concerns Diamond Respiratory Care Inc, with an inspection on November 18, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Diamond Respiratory Care Inc
- Inspection Date
- November 18, 2014
- Product Type
- Drugs
View Company Profile
ID · c41521ad-f633-4d58-83e4-362016fe65c6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 904406
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 211.100(a)Approval and review of procedures
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