IV Solutions of Lubbock
Form 483 issued June 8, 2007 · Lubbock, Texas
- Inspection
- Jun 5 – Jun 8, 2007
- Investigator
- David M. Beltran
- Observations
- 9
- Pages
- 2
- FEI number
- 3006311680
In short: On June 8, 2007, FDA issued a Form 483 with 9 observations to IV Solutions of Lubbock in Lubbock, Texas (FEI 3006311680) after an inspection that ran Jun 5 – Jun 8, 2007. The investigator was David M. Beltran. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and production account for 7 of 9 observations.
Most cited: 21 CFR 211.166 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The product is not routinely or periodically tested for sterility to demonstrate process control and the…
- 02
The above referenced product is not tested for…
- 03
The phannacy is currently assigning a ninety day expiration date for the product based on contract…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
David M. Beltran
1 document · 2007
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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at IV Solutions of Lubbock?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected IV Solutions of Lubbock?
David M. Beltran is named on this Form 483, for the inspection of Jun 5 – Jun 8, 2007. Each investigator has a profile showing what they cite most.
When was IV Solutions of Lubbock inspected by FDA?
The inspection ran Jun 5 – Jun 8, 2007, and the Form 483 is dated June 8, 2007.
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.