Park Infusioncare LP
Form 483 issued July 11, 2017 · Dallas, Texas
- Inspection
- Jun 27 – Jul 11, 2017
- Investigator
- Anh Lac
- Observations
- 5
- Pages
- 3
- FEI number
- 3013330273
In short: On July 11, 2017, FDA issued a Form 483 with 5 observations to Park Infusioncare LP in Dallas, Texas (FEI 3013330273) after an inspection that ran Jun 27 – Jul 11, 2017. The investigator was Anh Lac. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Vermin was observed in…
- 02
Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with…
- 03
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 04
Disinfecting agents and cleaning pads or wipes used in the ISO 5 area (aseptic processing…
This inspection in context
Anh Lac
13 documents · 2012–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmPark Infusioncare LP history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Park Infusioncare LP?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Park Infusioncare LP?
Anh Lac is named on this Form 483, for the inspection of Jun 27 – Jul 11, 2017. Each investigator has a profile showing what they cite most.
When was Park Infusioncare LP inspected by FDA?
The inspection ran Jun 27 – Jul 11, 2017, and the Form 483 is dated July 11, 2017.
How do I get the full Form 483 for Park Infusioncare LP?
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.