KC Pharmaceuticals, Inc.
Form 483 issued January 30, 2020 · Pomona, California
- Investigator
- Diane R. Weidley
- Observations
- 6
- Pages
- 8
- FEI number
- 2026940
In short: On January 30, 2020, FDA issued a Form 483 with 6 observations to KC Pharmaceuticals, Inc. in Pomona, California (FEI 2026940). The investigator was Diane R. Weidley. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the…
This inspection in context
Diane R. Weidley
3 documents · 2019–2020
Cites 211.110 (sampling and testing of in-process materials and drug products) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KC Pharmaceuticals, Inc.?
FDA listed 6 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.?
Diane R. Weidley is named on this Form 483. Each investigator has a profile showing what they cite most.
When was KC Pharmaceuticals, Inc. inspected by FDA?
This Form 483 is dated January 30, 2020.
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.