KC Pharmaceuticals, Inc.
Form 483 issued February 13, 2023 · Pomona, California
- Inspection
- Jan 18 – Feb 13, 2023
- Investigators
- Amir Alavi· Christopher R. Czajka
- Observations
- 10
- Pages
- 10
- FEI number
- 2026940
In short: On February 13, 2023, FDA issued a Form 483 with 10 observations to KC Pharmaceuticals, Inc. in Pomona, California (FEI 2026940) after an inspection that ran Jan 18 – Feb 13, 2023. The investigators were Amir Alavi and Christopher R. Czajka. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Amir Alavi
9 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) 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 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KC Pharmaceuticals, Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected KC Pharmaceuticals, Inc.?
Amir Alavi and Christopher R. Czajka are named on this Form 483, for the inspection of Jan 18 – Feb 13, 2023. Each investigator has a profile showing what they cite most.
When was KC Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 18 – Feb 13, 2023, and the Form 483 is dated February 13, 2023.
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.