FDA Inspection
Nova Homeopathic Therapeutics IncNova Homeopathic Therapeutics Inc – FDA Inspection, Oct 12, 2016
Record Details
This FDA Inspection record concerns Nova Homeopathic Therapeutics Inc, with an inspection on October 12, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 85e5d9f5-2564-4600-87f6-5a2e0ad067be
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 989865
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.142(a)Quarantine - written procedures
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(a)Procedures to be written and followed
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