Lincare, Inc.
FDA inspection history across 2 sites, 2004 to 2018
- 2
- Close-outs
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2004: one warning letter; 2015: one Form 483; 2016: one close-out letter; 2017: one Form 483; 2018: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One warning letter, at Clearwater, Florida.
- 2015–18Two Form 483s and two close-out letters, at Little Rock, Arkansas and Clearwater, Florida.
- 2015The longest 483 on file: 5 observations over 7 pages at Little Rock, Arkansas.
Cited most
Across all Lincare observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.28Personnel responsibilities1
The complete Lincare file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Clearwater, Florida
Two close-out letters and one warning letter · 2004 to 2018
Latest: Close-out, Mar 5, 2018 →Little Rock, Arkansas
Two Form 483s · 2015 to 2017 · 6 observations
Latest: Form 483, Aug 22, 2017 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-03-05 | Close-out Close-out letter | Clearwater, Florida | — | $99 |
| 2017-08-22 | 483 Form 483 | Little Rock, Arkansas | 1 | $99 |
| 2016-04-25 | Close-out Close-out letter | Clearwater, Florida | — | $99 |
| 2015-06-12 | 483 Form 483 | Little Rock, Arkansas | 5 | $99 |
| 2004-12-09 | Warning letter Warning letter | Clearwater, Florida | — | $99 |
Investigators on these documents
Jason R. Caballero (1)Latorie S. Jones (1)Matthew R. Maddox (1)Shelby N. Marler (1)
FEI number 3011564121 · most recent document Mar 5, 2018
About Lincare, Inc.
How many FDA Form 483s has Lincare, Inc. received?
FDA Intel has 2 Form 483s on file for Lincare, Inc.; the most recent is dated Aug 22, 2017.
When was Lincare, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Lincare, Inc. is a Form 483 dated Aug 22, 2017, for the site in Little Rock, Arkansas.
What did FDA cite at Lincare, Inc.?
The regulations cited most in the observations on file for Lincare, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.28 (Personnel responsibilities), 1 time.
Has Lincare, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Lincare, Inc.; the most recent is dated Dec 9, 2004.