FDA Inspection
Rxhomeo Private LimitedRxhomeo Private Limited – FDA Inspection, Feb 1, 2019
Record Details
This FDA Inspection record concerns Rxhomeo Private Limited, with an inspection on February 1, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 5fd96d82-75b9-4de1-8aa5-13c3fd053e0d
Inspection Facts
- Inspection number
- 1077814
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.101(c)(1)Q.C. release check by second individual
- 21 CFR 211.101(d)Component release checked by 2nd person
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.160(b)(1)Determination of conformance
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
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Other FDA inspections of Rxhomeo Private Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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