Drug establishmentActive, Registered FY2026FDA warning letter on file
GADAL Laboratories, Inc
GADAL Laboratories, Inc is an FDA-registered drug establishment (FEI 3008611487) located in Miami, Florida. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2023-02-17) 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
Aug 9, 2019 · Voluntary Action Indicated (VAI)
Apr 28, 2016 · Voluntary Action Indicated (VAI)
Apr 28, 2016 · No Action Indicated (NAI)
Jan 23, 2013 · Voluntary Action Indicated (VAI)
Apr 28, 2016, 5 observations: Review of representative number of batches; Suitability of testing methods verified; Testing Each Component for Conformity with Specs
Jan 23, 2013, 20 observations: Calibration/Inspection/Checking not done; Annual visual exams of drug products; Component - qualify supplier
FDA record timeline
Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.
Questions
Is GADAL Laboratories, Inc registered with the FDA?
Yes. GADAL Laboratories, Inc is an FDA-registered drug establishment (FEI 3008611487) in Miami, Florida. Its current registration status is Active, Registered FY2026.
Has GADAL Laboratories, Inc received an FDA warning letter?
Yes. FDA issued a warning letter to GADAL Laboratories, Inc; the most recent is dated Aug 15, 2023 (CGMP/Finished Pharmaceuticals/Adulterated).
What does GADAL Laboratories, Inc do?
GADAL Laboratories, Inc's FDA-registered operations are: Manufacturing.
Related facilities
Source: FDA public data · status as of 2026-08-22