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Coastal Bend Blood Center FDA Inspection Record

FEI 1671283 · Inspections, Form 483s, warning letters and import refusals

Coastal Bend Blood Center is an FDA-inspected facility (FEI 1671283) located in Corpus Christi, TX, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 28, 2025: No Action Indicated (NAI)
Inspections on record
7 (2 VAI, 5 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
29, latest Mar 5, 2025

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 28, 2025No Action Indicated (NAI)No citations listed
Jun 13, 2019No Action Indicated (NAI)No citations listed
Jul 14, 2017Voluntary Action Indicated (VAI)Equipment calibration frequency (21 CFR 606.60(b))
Jun 17, 2015No Action Indicated (NAI)No citations listed
Apr 12, 2013No Action Indicated (NAI)No citations listed
Jun 15, 2011No Action Indicated (NAI)No citations listed
Jun 8, 2009Voluntary Action Indicated (VAI)No citations listed

Recalls

Showing the 10 most recent of 29 recalls. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Mar 5, 2025Class IIB-0058-2026Red Blood Cells, Leukocytes Reduced
Red Blood Cells, Leukocytes Reduced, collected from a donor who had traveled to an area designated as endemic for malaria, were distributed.
Feb 21, 2024Class IIB-0259-2024Red Blood Cells, Leukocytes Reduced, Irradiated
Red Blood Cell products, for which donor eligibility was incomplete, were distributed.
Jan 15, 2024Class IIB-0194-2024Apheresis Platelets, Leukocytes Reduced
Apheresis Platelet products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Mar 24, 2023Class IIB-0590-2023Red Blood Cells, Leukocytes Reduced
Leukoreduced Red Blood Cells, collected from a donor who had recently traveled to a malarial endemic area, were distributed.
Sep 9, 2022Class IIB-0288-2023Red Blood Cells, Leukocytes Reduced, Irradiated
Leukoreduced Red Blood Cell products, which were inadequately irradiated due to lack of calibration of the irradiation device, were…
Jun 1, 2022Class IIIB-0007-2023Apheresis Red Blood Cells, Leukocytes Reduced
Red Blood Cell product, which were processed with expired reagents, was distributed.
Aug 9, 2021Class IIIB-0614-2021Pooled Cryoprecipitated AHF
Pooled Cryoprecipitated AHF, which did not have cryo QC performed, was distributed.
Jul 17, 2021Class IIB-0548-2021Platelets and 1 more product
Blood products, collected from a donor who lived in a malarial endemic area, were distributed.
Nov 16, 2020Class IIB-0184-2021Platelets
Platelet product, collected from a donor previously deferred for testing reactive for syphilis and was not properly tested for re-entry, was…
Nov 13, 2020Class IIIB-0233-2021Red Blood Cells, Leukocytes Reduced
Misbranded Blood Products were distributed.

FDA record score

21 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.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

26 records behind this number
RecordDatePoints x age weightAdds
Class II recall B-0058-2026, this FEI as the recalling firmMar 5, 20254 x 14
Class II recall B-0259-2024, this FEI as the recalling firmFeb 21, 20244 x 0.62.4
Class II recall B-0194-2024, this FEI as the recalling firmJan 15, 20244 x 0.62.4
Class II recall B-0590-2023, this FEI as the recalling firmMar 24, 20234 x 0.62.4
Class II recall B-0288-2023, this FEI as the recalling firmSep 9, 20224 x 0.62.4
Inspection classified VAIJul 14, 20176 x 0.251.5
Class II recall B-0548-2021, this FEI as the recalling firmJul 17, 20214 x 0.251
Class II recall B-0184-2021, this FEI as the recalling firmNov 16, 20204 x 0.251
Class II recall B-0138-2021, this FEI as the recalling firmOct 30, 20204 x 0.251
Class II recall B-0534-2020, this FEI as the recalling firmMar 18, 20204 x 0.251
Class II recall B-0728-2017, this FEI as the recalling firmMay 24, 20174 x 0.251
Class II recall B-0339-2017, this FEI as the recalling firmDec 19, 20164 x 0.251
Class II recall B-0293-2017, this FEI as the recalling firmNov 7, 201610 years or older, so it adds no points0
Class II recall B-0294-16, this FEI as the recalling firmJan 27, 201610 years or older, so it adds no points0
Class II recall B-0796-14, this FEI as the recalling firmMay 9, 201410 years or older, so it adds no points0
Class II recall B-1613-13, this FEI as the recalling firmFeb 20, 201310 years or older, so it adds no points0
Class II recall B-1194-13, this FEI as the recalling firmFeb 4, 201310 years or older, so it adds no points0
Inspection classified VAIJun 8, 200910 years or older, so it adds no points0
Class II recall B-0480-08, this FEI as the recalling firmFeb 13, 200710 years or older, so it adds no points0
Class II recall B-0621-08, this FEI as the recalling firmApr 28, 200610 years or older, so it adds no points0
Class II recall B-0295-7, this FEI as the recalling firmSep 12, 200510 years or older, so it adds no points0
Class II recall B-0292-7, this FEI as the recalling firmMay 2, 200510 years or older, so it adds no points0
Class II recall B-1582-5, this FEI as the recalling firmDec 3, 200410 years or older, so it adds no points0
Class II recall B-1393-5, this FEI as the recalling firmApr 1, 200310 years or older, so it adds no points0
Class II recall B-1060-5, this FEI as the recalling firmSep 19, 200210 years or older, so it adds no points0
Class II recall B-1360-5, this FEI as the recalling firmSep 8, 200210 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Coastal Bend Blood Center
Location
Corpus Christi, TX (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.