FDA Inspection
Grifols Bio Supplies IncGrifols Bio Supplies Inc – FDA Inspection, Oct 14, 2016
Record Details
This FDA Inspection record concerns Grifols Bio Supplies Inc, with an inspection on October 14, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Colleen M. Aspinwall (Issuing Officer)
- Ivan E. Reyes (Issuing Officer)
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ID · f79adcdc-f4c5-4ccc-9c5d-bb89095d2cbb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 999080
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 630.5(d)CPR certification
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 630.10(e)(2)Additional Medical Assessment Factors
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.65(e)Following manufacturer's instructions
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Other FDA inspections of Grifols Bio Supplies Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 19, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 14, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 20, 2010 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Grifols Bio Supplies Inc
- FDA Inspection 1314386 - 2026-04-23
- FDA Inspection 1206254 - 2023-05-19
- FDA Inspection 1083344 - 2019-03-14
- FDA Inspection 680693 - 2010-10-20
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