FDA Inspection
Rowny Systems, Inc.Rowny Systems, Inc. – FDA Inspection, Sep 17, 2019
Record Details
This FDA Inspection record concerns Rowny Systems, Inc., with an inspection on September 17, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · db986425-10c6-4fec-b058-3f811afdb022
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102059
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Rowny Systems, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2022 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 10, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Rowny Systems, Inc.
- FDA Inspection 1172078 - 2022-06-17
- FDA Inspection 866244 - 2014-02-10
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