Lubline, LLC
Form 483 issued September 1, 2015 · The Woodlands, Texas
- Inspection
- Aug 21 – Sep 1, 2015
- Investigator
- Lahore S. Ross
- Observations
- 2
- Pages
- 2
- FEI number
- 3008767875
In short: On September 1, 2015, FDA issued a Form 483 with 2 observations to Lubline, LLC in The Woodlands, Texas (FEI 3008767875) after an inspection that ran Aug 21 – Sep 1, 2015. The investigator was Lahore S. Ross. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.165 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Written complaint file records involving a drug product are not maintained until at least 1…
This inspection in context
Lahore S. Ross
1 document · 2015
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Texas.
The firmLubline, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lubline, LLC?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Lubline, LLC?
Lahore S. Ross is named on this Form 483, for the inspection of Aug 21 – Sep 1, 2015. Each investigator has a profile showing what they cite most.
When was Lubline, LLC inspected by FDA?
The inspection ran Aug 21 – Sep 1, 2015, and the Form 483 is dated September 1, 2015.
How do I get the full Form 483 for Lubline, LLC?
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.