QOL Medical, LLC
Form 483 issued August 30, 2019 · CLEARWATER, Florida
- Inspection
- Aug 27 – Aug 30, 2019
- Investigator
- Jose Velez
- Observations
- 1
- Pages
- 1
- FEI number
- 3014492051
In short: On August 30, 2019, FDA issued a Form 483 with 1 observation to QOL Medical, LLC in CLEARWATER, Florida (FEI 3014492051) after an inspection that ran Aug 27 – Aug 30, 2019. The investigator was Jose Velez. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to properly execute and document preventive maintenance to justify the lack of calibration…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmQOL Medical, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at QOL Medical, LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected QOL Medical, LLC?
Jose Velez is named on this Form 483, for the inspection of Aug 27 – Aug 30, 2019. Each investigator has a profile showing what they cite most.
When was QOL Medical, LLC inspected by FDA?
The inspection ran Aug 27 – Aug 30, 2019, and the Form 483 is dated August 30, 2019.
How do I get the full Form 483 for QOL Medical, 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.