Med-Pharmex, Inc
Form 483 issued May 17, 2019 · Pomona, California
- Inspection
- May 1 – May 17, 2019
- Investigator
- Walden H. Lee
- Observations
- 12
- Pages
- 14
- FEI number
- 2023614
In short: On May 17, 2019, FDA issued a Form 483 with 12 observations to Med-Pharmex, Inc in Pomona, California (FEI 2023614) after an inspection that ran May 1 – May 17, 2019. The investigator was Walden H. Lee. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacturing, processing and packing of a drug product are not maintained in…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Procedures describng the handlng of written and oral complaints related to drug products are deficiently written…
- 04
Written records of mvestigations into unexplained discrepancies do not always include the conclusions and follow-up. (Repeat…
This inspection in context
Walden H. Lee
23 documents · 2013–2026
Cites 211.165 (testing and release for distribution) 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 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Med-Pharmex, Inc?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. 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?
Walden H. Lee is named on this Form 483, for the inspection of May 1 – May 17, 2019. Each investigator has a profile showing what they cite most.
When was Med-Pharmex, Inc inspected by FDA?
The inspection ran May 1 – May 17, 2019, and the Form 483 is dated May 17, 2019.
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.