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Department of Defense - Air Force

FDA establishment 1577551, Dayton, Ohio, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 7
  • Official action indicated: 0
  • Last inspection ended: Apr 14, 2025
  • Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

Most Cited at This Site

Inspections citing each reference

Inspections

7 inspections, newest first
EndedProduct and areaCitationsClassification
Apr 14, 2025Biologics · Blood and Blood Products
1 cited reference
  • 21 CFR 630.40(c). Notification w/in 8 weeks Failure to make reasonable attempts to notify the donor within 8 weeks after determining that the donor was deferred or determined not to be eligible for donation.
Voluntary Action Indicated (VAI)
Mar 30, 2022Biologics · Blood and Blood ProductsBiologics · Vaccines and Allergenic Products
1 cited reference
  • 21 CFR 630.10(g)(1). Proof Of Identity Failure to obtain from the donor on the day of donation a postal address where the donor may be contacted for 8 weeks after donation.
Voluntary Action Indicated (VAI)
Sep 26, 2019Biologics · Blood and Blood Products
2 cited references
  • 21 CFR 606.160(a)(2). Determination of lot numbers and supplies Appropriate records are not available to determine the lot numbers of supplies used for specific units of the final product.
  • 21 CFR 610.47(a)(3). Notify Consignees [Collecting Establishment] Failure to notify consignees of the results of the reactive screening test within 45 calendar days after the donor tests reactive for evidence of HCV infection under the regulations.
Voluntary Action Indicated (VAI)
Sep 19, 2017Biologics · Blood and Blood ProductsNone postedNo Action Indicated (NAI)
Aug 7, 2015Biologics · Blood and Blood Products
2 cited references
  • 21 CFR 600.14(c). When to report Biological product deviations were not reported within the 45 calendar day timeframe.
  • 21 CFR 606.40(a)(1). Provide space for examination Failure to provide adequate space for private examinations of individuals to determine their suitability as blood donors.
Voluntary Action Indicated (VAI)
Dec 21, 2012Biologics · Blood and Blood ProductsNone postedNo Action Indicated (NAI)
Dec 21, 2010Biologics · Blood and Blood ProductsNone postedNo Action Indicated (NAI)

Identifiers

FEI number
1577551
FDA firm profile
Data Dashboard

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.