FDA Inspection
R & B Medical Group Inc.R & B Medical Group Inc. – FDA Inspection, Sep 25, 2019
Record Details
This FDA Inspection record concerns R & B Medical Group Inc., with an inspection on September 25, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 456a9d98-111a-4607-ae74-5f45133e76e2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1102975
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
6- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.270(b)Management system re: core CGTPs
- 21 CFR 1271.170(a)Sufficient number
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 1271.80(c)Manufacturer instructions not followed
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Other FDA inspections of R & B Medical Group Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 14, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for R & B Medical Group Inc.
- FDA Inspection 1150365 - 2021-08-12
- FDA Inspection 977932 - 2016-06-14
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