FDA Inspection
Grifols Biologicals LLCGrifols Biologicals LLC – FDA Inspection, Sep 17, 2026
Record Details
This FDA Inspection record concerns Grifols Biologicals LLC, with an inspection on September 17, 2026, issued by the Los Angeles District Office, covering biologics.
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ID · cbba883c-3001-4658-91fc-12e99bf88de4
Inspection Facts
- Inspection number
- 1336990
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 600.80(c)(1)(i)Reporting Requirements - 15-day alert
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Other FDA inspections of Grifols Biologicals LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 12, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 31, 2019 | Not classified | Los Angeles District Office | |
| August 24, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 20, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Grifols Biologicals LLC
- FDA Inspection 1229139 - 2024-05-03
- FDA Inspection 1105923 - 2019-09-12
- FDA Inspection 1088286 - 2019-01-31
- FDA Inspection 1027351 - 2017-08-24
- FDA Inspection 944819 - 2015-10-20
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