Drug establishmentActive, Registered FY2026Official Action Indicated

KC Pharmaceuticals, Inc.

KC Pharmaceuticals, Inc. is an FDA-registered drug establishment (FEI 2026940) located in Pomona, California. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2026-02-13) was classified OAI.

Establishment record

FEI Number

2026940

Address

3201 Producer Way, Pomona, California

Establishment type

Drug establishment

Products / operations

Labeling, Manufacturing, Packaging

Registration status

Active, Registered FY2026

Verify this record in FDA source data ›

Inspection history

Inspections on file

Feb 13, 2026 · Official Action Indicated (OAI)
Aug 28, 2024 · Voluntary Action Indicated (VAI)
Feb 13, 2023 · Official Action Indicated (OAI)
Jan 30, 2020 · Voluntary Action Indicated (VAI)
Nov 16, 2017 · Voluntary Action Indicated (VAI)
Mar 19, 2015 · Voluntary Action Indicated (VAI)
May 23, 2014 · No Action Indicated (NAI)
May 23, 2014 · Voluntary Action Indicated (VAI)
Jun 10, 2013 · Official Action Indicated (OAI)
Jun 10, 2013 · No Action Indicated (NAI)
Aug 1, 2012 · Voluntary Action Indicated (VAI)
Feb 14, 2011 · Voluntary Action Indicated (VAI)

Form 483 observations

Feb 13, 2026, 13 observations: Objectionable microbiological contamination; Procedures not in writing, fully followed; Aseptic Processing Area
Aug 28, 2024, 6 observations: Validation lacking for sterile drug products; Second person sign off; Label storage access limited to authorized personnel
Feb 13, 2023, 10 observations: Control procedures to monitor and validate performance; Cleaning System; Equipment for Environmental Control
Jan 30, 2020, 6 observations: Equipment for Environmental Control; Procedures for sterile drug products; Written procedures lacking for use of pesticides etc.
Nov 16, 2017, 5 observations: Complete test data included in records; Computer control of master formula records; Record maintenance 1 year (except exempt OTC)
Mar 19, 2015, 7 observations: Written record of investigation incomplete; Calibration/Inspection/Checking not done; Returned drug products identified and held

FDA record timeline

Feb 13, 2026

FDA inspection

OAI classification

Feb 13, 2026

Form 483

13 observations

Aug 28, 2024

FDA inspection

VAI classification

Aug 28, 2024

Form 483

6 observations

Feb 13, 2023

FDA inspection

OAI classification

Feb 13, 2023

Form 483

10 observations

Jan 30, 2020

FDA inspection

VAI classification

Jan 30, 2020

Form 483

6 observations

Nov 16, 2017

FDA inspection

VAI classification

Nov 16, 2017

Form 483

5 observations

Mar 19, 2015

FDA inspection

VAI classification

Mar 19, 2015

Form 483

7 observations

May 23, 2014

FDA inspection

NAI classification

May 23, 2014

FDA inspection

VAI classification

Jun 10, 2013

FDA inspection

OAI classification

Jun 10, 2013

FDA inspection

NAI classification

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

Questions

Is KC Pharmaceuticals, Inc. registered with the FDA?

Yes. KC Pharmaceuticals, Inc. is an FDA-registered drug establishment (FEI 2026940) in Pomona, California. Its current registration status is Active, Registered FY2026.

Has KC Pharmaceuticals, Inc. received an FDA warning letter?

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

What does KC Pharmaceuticals, Inc. do?

KC Pharmaceuticals, Inc.'s FDA-registered operations are: Labeling, Manufacturing, Packaging.

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