Drug establishmentActive, Registered FY2026Official Action Indicated

Chemco Corporation

Chemco Corporation is an FDA-registered drug establishment (FEI 1042599) located in Hialeah, Florida. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2025-08-22) was classified OAI.

Establishment record

FEI Number
1042599
Address
4920 NW 165th St, Hialeah, Florida
Establishment type
Drug establishment
Products / operations
Manufacturing
Registration status
Active, Registered FY2026

Verify this record in FDA source data ›

Inspection history

Inspections on file
Aug 22, 2025 · Official Action Indicated (OAI)
Feb 12, 2019 · Official Action Indicated (OAI)
Mar 6, 2017 · Voluntary Action Indicated (VAI)
Form 483 observations
Aug 22, 2025, 8 observations: Reports of Analysis (Components); Investigations of discrepancies, failures; Written procedures not established/followed
Feb 12, 2019, 4 observations: Written complaint record to be maintained at facility; No written record of investigation; Accurate reproduction included
Mar 6, 2017, 6 observations: Microbiological testing; Written records kept in individual logs; Testing and release for distribution

FDA record timeline

FDA inspection
OAI classification
Form 483
8 observations
FDA inspection
OAI classification
Form 483
4 observations
FDA inspection
VAI classification
Form 483
6 observations

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is Chemco Corporation registered with the FDA?

Yes. Chemco Corporation is an FDA-registered drug establishment (FEI 1042599) in Hialeah, Florida. Its current registration status is Active, Registered FY2026.

Has Chemco Corporation received an FDA warning letter?

FDA has not posted a warning letter for Chemco Corporation. FDA publishes only a subset of enforcement records, so this is not a guarantee.

What does Chemco Corporation do?

Chemco Corporation's FDA-registered operations are: Manufacturing.

Related facilities

Source: FDA public data · status as of 2026-08-22

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