Lincare, Inc.
Form 483 issued June 12, 2015 · Little Rock, Arkansas
- Inspection
- Jun 1 – Jun 12, 2015
- Investigators
- Latorie S. Jones· Matthew R. Maddox· Shelby N. Marler
- Observations
- 5
- Pages
- 7
- FEI number
- 3011564121
In short: On June 12, 2015, FDA issued a Form 483 with 5 observations to Lincare, Inc. in Little Rock, Arkansas (FEI 3011564121) after an inspection that ran Jun 1 – Jun 12, 2015. The investigators were Latorie S. Jones, Matthew R. Maddox and Shelby N. Marler. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.42 (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
Aseptic processing areas are deficient regarding the system…
- 02
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lincare, Inc.?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. 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 Lincare, Inc.?
Latorie S. Jones, Matthew R. Maddox and Shelby N. Marler are named on this Form 483, for the inspection of Jun 1 – Jun 12, 2015. Each investigator has a profile showing what they cite most.
When was Lincare, Inc. inspected by FDA?
The inspection ran Jun 1 – Jun 12, 2015, and the Form 483 is dated June 12, 2015.
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.