BPC Plasma, Inc. — FDA Facility Profile
BPC Plasma, Inc. is an FDA-inspected facility (FEI 1072432) located in Gainesville, FL, US. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jul 19, 2023: No Action Indicated (NAI)
- Inspections on record
- 8 (8 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
- 5, latest Jun 26, 2020
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jul 19, 2023 | No Action Indicated (NAI) | No citations listed |
| Sep 20, 2019 | No Action Indicated (NAI) | No citations listed |
| May 24, 2017 | No Action Indicated (NAI) | No citations listed |
| May 28, 2015 | No Action Indicated (NAI) | No citations listed |
| Mar 20, 2013 | No Action Indicated (NAI) | No citations listed |
| Sep 13, 2012 | No Action Indicated (NAI) | No citations listed |
| Dec 15, 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 |
|---|---|---|---|
| Jun 26, 2020 | Not yet classified | B-0632-2020 | Source Plasma Source Plasma, for which donor eligibility screening was incomplete, were distributed. |
| Aug 22, 2016 | Not yet classified | B-0050-2017 | Source Plasma Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. |
| Aug 2, 2016 | Not yet classified | B-0027-2017 | Source Plasma Blood product,s collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. |
| Apr 12, 2005 | Not yet classified | B-1678-6 | Source Plasma, collected from a donor who had received a piercing within 12 months of… Source Plasma, collected from a donor who had received a piercing within 12 months of donation, was distributed. |
| Jan 20, 2005 | Not yet classified | B-1679-6 | Source Plasma Blood products, collected from a donor for whom post-donation information was received regarding a previous deferralfor unacceptable viral… |
Facility details
- Company
- BPC Plasma, Inc.
- Location
- Gainesville, FL (US)
- Source
- inspections