Med-Pharmex, Inc
Form 483 issued December 18, 2023 · Pomona, California
- Inspection
- Dec 4 – Dec 18, 2023
- Investigators
- Christopher R. Czajka· Walden H. Lee
- Observations
- 4
- Pages
- 8
- FEI number
- 2023614
In short: On December 18, 2023, FDA issued a Form 483 with 4 observations to Med-Pharmex, Inc in Pomona, California (FEI 2023614) after an inspection that ran Dec 4 – Dec 18, 2023. The investigators were Christopher R. Czajka and Walden H. Lee. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
3 of 4 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 03
Written production and process control procedures are not documented at…
- 04
Components for drug product manufacturing are not weighed…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmMed-Pharmex, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Med-Pharmex, Inc?
FDA listed 4 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Med-Pharmex, Inc?
Christopher R. Czajka and Walden H. Lee are named on this Form 483, for the inspection of Dec 4 – Dec 18, 2023. Each investigator has a profile showing what they cite most.
When was Med-Pharmex, Inc inspected by FDA?
The inspection ran Dec 4 – Dec 18, 2023, and the Form 483 is dated December 18, 2023.
How do I get the full Form 483 for Med-Pharmex, 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.