Drug establishmentActive, Registered FY2026FDA warning letter on file
Accupack Midwest
Accupack Midwest is an FDA-registered drug establishment (FEI 1000122754) located in Cincinnati, Ohio. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2025-07-23) was classified OAI. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.
Establishment record
Inspection history
Feb 27, 2024 · Official Action Indicated (OAI)
Jun 17, 2016 · Voluntary Action Indicated (VAI)
Oct 11, 2012 · Voluntary Action Indicated (VAI)
Sep 16, 2011 · Voluntary Action Indicated (VAI)
Aug 12, 2009 · Voluntary Action Indicated (VAI)
Jun 17, 2016, 9 observations: Lack of written stability program; Handling and Storage to Prevent Contamination; Calibration/Inspection/Checking not done
Oct 11, 2012, 17 observations: Acceptance of drug products; Lack of written stability program; Drug products-sampling procedures/specifications
Aug 12, 2009, 9 observations: Drug products-sampling procedures/specifications; Calibration/Inspection/Checking not done; Lack of quality control unit
Questions
Is Accupack Midwest registered with the FDA?
Yes. Accupack Midwest is an FDA-registered drug establishment (FEI 1000122754) in Cincinnati, Ohio. Its current registration status is Active, Registered FY2026.
Has Accupack Midwest received an FDA warning letter?
Yes. FDA issued a warning letter to Accupack Midwest; the most recent is dated Aug 15, 2024 (CGMP/Finished Pharmaceuticals/Adulterated).
What does Accupack Midwest do?
Accupack Midwest's FDA-registered operations are: Labeling, Manufacturing, Packaging, Relabeling, Repackaging.
Related facilities
Source: FDA public data · status as of 2026-06-06