American National Red Cross, The FDA Inspection Record
American National Red Cross, The is an FDA-inspected facility (FEI 2675945) located in San Juan, PR, US. RegDataLab tracks 10 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Dec 14, 2023: No Action Indicated (NAI)
- Inspections on record
- 10 (10 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 11, latest Mar 11, 2014
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 14, 2023 | No Action Indicated (NAI) | No citations listed |
| Apr 29, 2022 | No Action Indicated (NAI) | No citations listed |
| Mar 7, 2018 | No Action Indicated (NAI) | No citations listed |
| Jan 29, 2016 | No Action Indicated (NAI) | No citations listed |
| Aug 29, 2014 | No Action Indicated (NAI) | No citations listed |
| Sep 18, 2013 | No Action Indicated (NAI) | No citations listed |
| Apr 13, 2012 | No Action Indicated (NAI) | No citations listed |
| Aug 11, 2011 | No Action Indicated (NAI) | No citations listed |
| May 21, 2010 | No Action Indicated (NAI) | No citations listed |
| May 8, 2009 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Mar 11, 2014 | Class III | B-0641-14 | Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated Blood product, labeled with an extended expiration date following irradiation, was distributed. |
| Jun 17, 2008 | Class II | B-1994-12 | Red Blood Cells and 1 more product Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. |
| Jul 25, 2007 | Class II | B-1917-08 | Recovered Plasma Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. |
| May 16, 2007 | Class III | B-0120-09 | Red Blood Cells (Apheresis) Leukocytes Reduced Blood products, which did not meet the requirement for red blood cell recovery, were distributed. |
| Apr 30, 2007 | Class II | B-0118-09 | Red Blood Cells Leukocytes Reduced and 1 more product Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. |
| Oct 6, 2006 | Class II | B-1918-08 | Fresh Frozen Plasma and 1 more product Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. |
| Sep 21, 2006 | Class III | B-1920-08 | Red Blood Cells Leukocytes Reduced and 2 more products Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. |
| Nov 16, 2005 | Class III | B-1872-08 | Red Blood Cells Leukocytes Reduced Blood products, which were incorrectly tested for red blood cell antigens, were distributed. |
| Aug 23, 2005 | Class II | B-1873-08 | Red Blood Cells Leukocytes Reduced and 1 more product Blood products, collected from donors who traveled to an area considered endemic for malaria, were distributed. |
| Jan 15, 2004 | Class II | B-1915-08 | Recovered Plasma and 1 more product Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. |
FDA record score
0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
7 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall B-1994-12, this FEI as the recalling firm | Jun 17, 2008 | 10 years or older, so it adds no points | 0 |
| Class II recall B-1917-08, this FEI as the recalling firm | Jul 25, 2007 | 10 years or older, so it adds no points | 0 |
| Class II recall B-0118-09, this FEI as the recalling firm | Apr 30, 2007 | 10 years or older, so it adds no points | 0 |
| Class II recall B-1918-08, this FEI as the recalling firm | Oct 6, 2006 | 10 years or older, so it adds no points | 0 |
| Class II recall B-1873-08, this FEI as the recalling firm | Aug 23, 2005 | 10 years or older, so it adds no points | 0 |
| Class II recall B-1915-08, this FEI as the recalling firm | Jan 15, 2004 | 10 years or older, so it adds no points | 0 |
| Class II recall B-1870-08, this FEI as the recalling firm | Date not listed | No date listed, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- American National Red Cross, The
- Location
- San Juan, PR (US)
- Source
- inspections