KC Pharmaceuticals, Inc.
FDA inspection history in Pomona, California, 2009 to 2026
- 4
- Form 483s
- 2
- Warning letters
Every document, by year
- Warning letter
- Form 483
2009: one Form 483; 2020: one Form 483; 2023: one warning letter and one Form 483; 2026: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One Form 483, at Pomona, California.
- 2020One Form 483, at Pomona, California.
- 2023One warning letter and one Form 483, at Pomona, California.
- 2026One warning letter and one Form 483, at Pomona, California.
- 2026The longest 483 on file: 13 observations over 39 pages at Pomona, California.
Cited most
Across all KC Pharmaceuticals observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products3
- 21 CFR 211.113(b)Control of microbiological contamination3
- 21 CFR 211.160(b)General requirements3
- 21 CFR 211.42(c)(10)Design and construction features3
The complete KC Pharmaceuticals file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Pomona, California
Four Form 483s and two warning letters · 2009 to 2026 · 37 observations
Latest: Warning letter, Aug 12, 2026 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-08-12 | Warning letter Warning letter | Pomona, California | — | $99 |
| 2026-02-13 | 483 Form 483 | Pomona, California | 13 | $99 |
| 2023-08-03 | Warning letter Warning letter | Pomona, California | — | $99 |
| 2023-02-13 | 483 Form 483 | Pomona, California | 10 | $99 |
| 2020-01-30 | 483 Form 483 | Pomona, California | 6 | $99 |
| 2009-12-30 | 483 Form 483 | Pomona, California | 8 | $99 |
Investigators on these documents
Amir Alavi (1)Brian P. Putz (1)Carla J. Lundi (1)Christopher R. Czajka (1)Crystal Monroy (1)Diane R. Weidley (1)Luis P. Torres (1)Nathan E. Hellman (1)Ngozi G. Offor (1)Pearl C. Ozuruigbo (1)Rowena S. Nguyen (1)Truong X. Nguyen (1)
FEI number 2026940 · most recent document Aug 12, 2026
About KC Pharmaceuticals, Inc.
How many FDA Form 483s has KC Pharmaceuticals, Inc. received?
FDA Intel has 4 Form 483s on file for KC Pharmaceuticals, Inc.; the most recent is dated Feb 13, 2026.
When was KC Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for KC Pharmaceuticals, Inc. is a Form 483 dated Feb 13, 2026, for the site in Pomona, California.
What did FDA cite at KC Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for KC Pharmaceuticals, Inc. are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 3 times; 21 CFR 211.113(b) (Control of microbiological contamination), 3 times.
Has KC Pharmaceuticals, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for KC Pharmaceuticals, Inc.; the most recent is dated Aug 12, 2026.