FDA Inspection
Healthcare Medical & Respiratory Care, IncFDA Inspection 791891 - Healthcare Medical & Respiratory Care, Inc - July 20, 2012
Record Details
This FDA Inspection record concerns Healthcare Medical & Respiratory Care, Inc, with an inspection on July 20, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 20, 2012
- Product Type
- Drugs
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ID · 90e7d646-45fb-4cd7-a8c6-7479896518e9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 791891
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of Healthcare Medical & Respiratory Care, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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