Park Infusioncare, LP dba Preferred Homecare

Form 483 issued February 17, 2017 · Houston, Texas

Inspection
Feb 13 – Feb 17, 2017
Investigator
Massoud Motamed
Observations
2
Pages
2
FEI number
3012669716

In short: On February 17, 2017, FDA issued a Form 483 with 2 observations to Park Infusioncare, LP dba Preferred Homecare in Houston, Texas (FEI 3012669716) after an inspection that ran Feb 13 – Feb 17, 2017. The investigator was Massoud Motamed. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and production account for 2 of 2 observations.

Facilities & equipment1
Production1

Most cited: 21 CFR 211.42 (1×) · 211.113 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Tbe facility design and maintenanCe was observed to allow the influx of poor quality air Into…

  2. 02

    The use of sporieidal age•ts in the elea•rooms and/or ISO 5 area…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

Questions about this 483

What did FDA find at Park Infusioncare, LP dba Preferred Homecare?

FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected Park Infusioncare, LP dba Preferred Homecare?

Massoud Motamed is named on this Form 483, for the inspection of Feb 13 – Feb 17, 2017. Each investigator has a profile showing what they cite most.

When was Park Infusioncare, LP dba Preferred Homecare inspected by FDA?

The inspection ran Feb 13 – Feb 17, 2017, and the Form 483 is dated February 17, 2017.

How do I get the full Form 483 for Park Infusioncare, LP dba Preferred Homecare?

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