Grifols Biomat USA, Inc. FDA Record
Grifols Biomat USA, Inc. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Grifols Biomat USA, Inc." is on file.
- Latest inspection
- Apr 23, 2026 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 23, 2026 | Worcester, MA | Biologics | No Action Indicated (NAI) | 3021124237 |
| Mar 24, 2025 | Fairless Hills, PA | Biologics | No Action Indicated (NAI) | 3013154786 |
| Nov 9, 2022 | Provo, UT | Biologics | No Action Indicated (NAI) | 1000306163 |
| Jan 23, 2019 | Fairless Hills, PA | Biologics | No Action Indicated (NAI) | 3013154786 |
| Mar 15, 2017 | Provo, UT | Biologics | No Action Indicated (NAI) | 1000306163 |
| Nov 15, 2011 | Provo, UT | Biologics | No Action Indicated (NAI) | 1000306163 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3021124237 | Worcester, MA | 1 | Apr 23, 2026 |
| FEI 3013154786 | Fairless Hills, PA | 2 | Mar 24, 2025 |
| FEI 1000306163 | Provo, UT | 3 | Nov 9, 2022 |
Grifols Biomat USA, Inc. and the FDA: common questions
Has Grifols Biomat USA, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Grifols Biomat USA, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Grifols Biomat USA, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Grifols Biomat USA, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Grifols Biomat USA, Inc.?
The most recent FDA inspection on file ended Apr 23, 2026 at Worcester, MA and was classified NAI. FDA has 6 inspections of Grifols Biomat USA, Inc. on file.
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