Lincare, Inc.
Form 483 issued August 22, 2017 · Little Rock, Arkansas
- Inspection
- Aug 14 – Aug 22, 2017
- Investigator
- Jason R. Caballero
- Observations
- 1
- Pages
- 2
- FEI number
- 3011564121
In short: On August 22, 2017, FDA issued a Form 483 with 1 observation to Lincare, Inc. in Little Rock, Arkansas (FEI 3011564121) after an inspection that ran Aug 14 – Aug 22, 2017. The investigator was Jason R. Caballero. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A disinfecting agent is used in the ISO 5 areas…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmLincare, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
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 Lincare, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. 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 Lincare, Inc.?
Jason R. Caballero is named on this Form 483, for the inspection of Aug 14 – Aug 22, 2017. Each investigator has a profile showing what they cite most.
When was Lincare, Inc. inspected by FDA?
The inspection ran Aug 14 – Aug 22, 2017, and the Form 483 is dated August 22, 2017.
How do I get the full Form 483 for Lincare, Inc.?
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.