MPRX, Inc. dba Medical Park Pharmacy
Form 483 issued November 22, 2019 · Dallas, Texas
- Inspection
- Nov 18 – Nov 22, 2019
- Investigator
- Claire M. Minden
- Observations
- 4
- Pages
- 2
- FEI number
- 3004102002
In short: On November 22, 2019, FDA issued a Form 483 with 4 observations to MPRX, Inc. dba Medical Park Pharmacy in Dallas, Texas (FEI 3004102002) after an inspection that ran Nov 18 – Nov 22, 2019. The investigator was Claire M. Minden. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.87 (retesting of approved components, drug product containers, and closures).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm released drug product in which the strength differs from, or its purity or quality…
- 02
Calibration of mechanical equipment is not performed daily or on a routine schedule designed…
- 03
You produced highly potent diugs without providing…
- 04
Vermin was observed in…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmMPRX, Inc. dba Medical Park Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.87
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MPRX, Inc. dba Medical Park Pharmacy?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.87 (retesting of approved components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected MPRX, Inc. dba Medical Park Pharmacy?
Claire M. Minden is named on this Form 483, for the inspection of Nov 18 – Nov 22, 2019. Each investigator has a profile showing what they cite most.
When was MPRX, Inc. dba Medical Park Pharmacy inspected by FDA?
The inspection ran Nov 18 – Nov 22, 2019, and the Form 483 is dated November 22, 2019.
How do I get the full Form 483 for MPRX, Inc. dba Medical Park Pharmacy?
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