RTI Biologics, Inc.
FDA inspection history in Alachua, Florida, 2004 to 2017
- 4
- EIRs
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
- EIR
2004: one inspection report; 2008: one inspection report; 2010: one inspection report; 2011: one inspection report; 2012: one Form 483; 2017: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One inspection report, at Alachua, Florida.
- 2008–12Three inspection reports and one Form 483, at Alachua, Florida.
- 2017One warning letter, at Alachua, Florida.
Cited most
Across all RTI Biologics observations on file
- 21 CFR 1271.195(a)Environmental control and monitoring3
- 21 CFR 1271.145Prevention of the introduction, transmission, or spread of communicable diseases1
- 21 CFR 1271.160(b)(3)Establishment and maintenance of a quality program1
- 21 CFR 1271.230(a)Process validation1
The complete RTI Biologics file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Alachua, Florida
Four inspection reports, one warning letter and one Form 483 · 2004 to 2017 · 6 observations
Latest: Warning letter, Nov 8, 2017 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-11-08 | Warning letter Warning letter | Alachua, Florida | — | $99 |
| 2012-07-11 | 483 Form 483 | Alachua, Florida | 6 | $99 |
| 2011-10-25 | EIR EIR | Alachua, Florida | — | $550 |
| 2010-10-15 | EIR EIR | Alachua, Florida | — | $550 |
| 2008-09-30 | EIR EIR | Alachua, Florida | — | $550 |
| 2004-10-15 | EIR EIR | Alachua, Florida | — | $550 |
Investigators on these documents
Barbara T. Carmichael (2)Julie D. Bringger (2)Ronnie E. Jackson (2)Valerie J. Grecek Trinh (2)Kip J. Hanks (1)Grecek Trinh (1)Jana L. Caylor (1)Susan M. Turcovski (1)
FEI number 3002719998 · most recent document Nov 8, 2017
About RTI Biologics, Inc.
How many FDA Form 483s has RTI Biologics, Inc. received?
FDA Intel has 1 Form 483 on file for RTI Biologics, Inc.; the most recent is dated Jul 11, 2012.
When was RTI Biologics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for RTI Biologics, Inc. is a Form 483 dated Jul 11, 2012, for the site in Alachua, Florida.
What did FDA cite at RTI Biologics, Inc.?
The regulations cited most in the observations on file for RTI Biologics, Inc. are 21 CFR 1271.195(a) (Environmental control and monitoring), 3 times; 21 CFR 1271.145 (Prevention of the introduction, transmission, or spread of communicable diseases), 1 time; 21 CFR 1271.160(b)(3) (Establishment and maintenance of a quality program), 1 time.
Has RTI Biologics, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for RTI Biologics, Inc.; the most recent is dated Nov 8, 2017.