FDA Inspection
Celularity IncFDA Inspection 1215480 - Celularity Inc - August 22, 2023
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Record Details
This FDA Inspection record concerns Celularity Inc, with an inspection on August 22, 2023, issued by the New Jersey District Office.
- Company
- Celularity Inc
- Inspection Date
- August 22, 2023
View Company Profile
ID · 112bc008-bf81-40b0-b929-91ec64f2fd55
Inspection Facts
- Inspection number
- 1215480
- FDA center
- Biologics
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)(5)Testing of reconstituted drugs
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Celularity Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2022 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |