Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
11 Jul 2012
21 CFR 1271.160(b)(3)
Actions verified, short and long term solutions
Cited by Barbara T Carmichael, Valerie J Grecek Trinh, Carla A Norris
11 Jul 2012
21 CFR 1271.160(b)(5)
Monitoring systems
Cited by Barbara T Carmichael, Valerie J Grecek Trinh, Carla A Norris
11 Jul 2012
21 CFR 1271.195(a)
Adequate control, proper conditions
Cited by Barbara T Carmichael, Valerie J Grecek Trinh, Carla A Norris
11 Jul 2012
21 CFR 1271.195(a)(1)
Temperature and humidity controls
Cited by Barbara T Carmichael, Valerie J Grecek Trinh, Carla A Norris
11 Jul 2012
21 CFR 1271.195(a)(3)
Aseptic processing---cleaning, disinfecting
Cited by Barbara T Carmichael, Valerie J Grecek Trinh, Carla A Norris
Inspected site
RSRTI Surgical, Inc.Alachua, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.160(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 8 observations
The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere