Device establishmentActive, RegisteredFDA warning letter on file
INCELL CORPORATION, LLC
INCELL CORPORATION, LLC is an FDA-registered device establishment (FEI 3004107906) located in SAN ANTONIO, Texas. The facility is active, registered. Its most recent FDA inspection on record (2023-09-29) 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
Sep 27, 2018 · No Action Indicated (NAI)
Sep 1, 2015 · Official Action Indicated (OAI)
Dec 19, 2013 · No Action Indicated (NAI)
Sep 1, 2015, 4 observations: Container label, outsourcer facility; Cleaning System; Environmental Monitoring System
FDA record timeline
Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.
Questions
Is INCELL CORPORATION, LLC registered with the FDA?
Yes. INCELL CORPORATION, LLC is an FDA-registered device establishment (FEI 3004107906) in SAN ANTONIO, Texas. Its current registration status is Active, Registered.
Has INCELL CORPORATION, LLC received an FDA warning letter?
Yes. FDA issued a warning letter to INCELL CORPORATION, LLC; the most recent is dated Dec 12, 2024 (CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated).
What does INCELL CORPORATION, LLC do?
INCELL CORPORATION, LLC's FDA-registered operations are: Microbiology, Manufacture Medical Device, Hematology.
Related facilities
Source: FDA public data · status as of 2026-08-22