FDA Inspection
Celltrion Pharm, Inc.Celltrion Pharm, Inc. – FDA Inspection, Sep 14, 2023
Record Details
This FDA Inspection record concerns Celltrion Pharm, Inc., with an inspection on September 14, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dfecf580-81e2-4327-8442-f3f986bb31c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1219108
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Celltrion Pharm, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 23, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 16, 2023 | Not classified | Office of Inspections and Investigations | |
| July 12, 2019 | Not classified | Office of Inspections and Investigations | |
| November 17, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Celltrion Pharm, Inc.
- FDA Inspection 1247299 - 2024-07-23
- FDA Inspection 1209014 - 2023-06-16
- FDA Inspection 1102190 - 2019-07-12
- FDA Inspection 1034680 - 2017-11-17
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