Med-Pharmex, Inc
Form 483 issued September 14, 2021 · Pomona, California
- Inspection
- Aug 23 – Sep 14, 2021
- Investigators
- Uttaniti Limchumroon· Walden H. Lee
- Observations
- 13
- Pages
- 20
- FEI number
- 2023614
In short: On September 14, 2021, FDA issued a Form 483 with 13 observations to Med-Pharmex, Inc in Pomona, California (FEI 2023614) after an inspection that ran Aug 23 – Sep 14, 2021. The investigators were Uttaniti Limchumroon and Walden H. Lee. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 9 of 13 observations.
Most cited: 21 CFR 211.160 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Procedures describing the handling of written and oral complaints related to drug products are…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
- 04
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Med-Pharmex, Inc?
FDA listed 13 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Med-Pharmex, Inc?
Uttaniti Limchumroon and Walden H. Lee are named on this Form 483, for the inspection of Aug 23 – Sep 14, 2021. Each investigator has a profile showing what they cite most.
When was Med-Pharmex, Inc inspected by FDA?
The inspection ran Aug 23 – Sep 14, 2021, and the Form 483 is dated September 14, 2021.
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.