KC Pharmaceuticals, Inc.
Form 483 issued February 13, 2026 · Pomona, California
- Inspection
- Jan 20 – Feb 13, 2026
- Investigators
- Crystal Monroy· Luis P. Torres· Nathan E. Hellman
- Observations
- 13
- Pages
- 39
- FEI number
- 2026940
In short: On February 13, 2026, FDA issued a Form 483 with 13 observations to KC Pharmaceuticals, Inc. in Pomona, California (FEI 2026940) after an inspection that ran Jan 20 – Feb 13, 2026. The investigators were Crystal Monroy, Luis P. Torres, Nathan E. Hellman, Ngozi G. Offor, Pearl C. Ozuruigbo, Rowena S. Nguyen, Truong X. Nguyen and Walden H. Lee. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Input to and output from the computer, related systems of formulas and records or data are…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Crystal Monroy
15 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmKC Pharmaceuticals, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KC Pharmaceuticals, Inc.?
FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected KC Pharmaceuticals, Inc.?
Crystal Monroy, Luis P. Torres, Nathan E. Hellman, Ngozi G. Offor, Pearl C. Ozuruigbo, Rowena S. Nguyen, Truong X. Nguyen and Walden H. Lee are named on this Form 483, for the inspection of Jan 20 – Feb 13, 2026. Each investigator has a profile showing what they cite most.
When was KC Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 20 – Feb 13, 2026, and the Form 483 is dated February 13, 2026.
How do I get the full Form 483 for KC Pharmaceuticals, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.