KC Pharmaceuticals, Inc.
Form 483 issued December 30, 2009 · Pomona, California
- Inspection
- Dec 15 – Dec 30, 2009
- Investigators
- Brian P. Putz· Carla J. Lundi
- Observations
- 8
- Pages
- 5
- FEI number
- 2026940
In short: On December 30, 2009, FDA issued a Form 483 with 8 observations to KC Pharmaceuticals, Inc. in Pomona, California (FEI 2026940) after an inspection that ran Dec 15 – Dec 30, 2009. The investigators were Brian P. Putz and Carla J. Lundi. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 5 of 8 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 03
The corrective and preventive action procedures addressing the investigation of the cause of nonconformities relating to…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Brian P. Putz
3 documents · 2009
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KC Pharmaceuticals, Inc.?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production & process controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected KC Pharmaceuticals, Inc.?
Brian P. Putz and Carla J. Lundi are named on this Form 483, for the inspection of Dec 15 – Dec 30, 2009. Each investigator has a profile showing what they cite most.
When was KC Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Dec 15 – Dec 30, 2009, and the Form 483 is dated December 30, 2009.
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.