IV Solutions of Lubbock
Form 483 issued March 20, 2013 · Lubbock, Texas
- Inspection
- Mar 18 – Mar 20, 2013
- Investigator
- Paul C. Mouris
- Observations
- 7
- Pages
- 4
- FEI number
- 3006311680
In short: On March 20, 2013, FDA issued a Form 483 with 7 observations to IV Solutions of Lubbock in Lubbock, Texas (FEI 3006311680) after an inspection that ran Mar 18 – Mar 20, 2013. The investigator was Paul C. Mouris. 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 6 of 7 observations.
Most cited: 21 CFR 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
Clothing ofpersonnel engaged in the processing of drug products is not appropriate for…
- 02
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Paul C. Mouris
4 documents · 2008–2013
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmIV Solutions of Lubbock history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at IV Solutions of Lubbock?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 IV Solutions of Lubbock?
Paul C. Mouris is named on this Form 483, for the inspection of Mar 18 – Mar 20, 2013. Each investigator has a profile showing what they cite most.
When was IV Solutions of Lubbock inspected by FDA?
The inspection ran Mar 18 – Mar 20, 2013, and the Form 483 is dated March 20, 2013.
How do I get the full Form 483 for IV Solutions of Lubbock?
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.