Overview
- 16 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
23 Mar 2018
21 CFR 111.12(c)
Personnel - education, training, experience
Cited by Alexandra A Carrico, Charles L Zhou
23 Mar 2018
21 CFR 111.12(c)
Personnel - education, training, experience
Cited by Alexandra A Carrico, Charles L Zhou
23 Mar 2018
21 CFR 111.455(a)
Hold - temperature, humidity, light
Cited by Alexandra A Carrico, Charles L Zhou
23 Mar 2018
21 CFR 111.455(a)
Hold - temperature, humidity, light
Cited by Alexandra A Carrico, Charles L Zhou
23 Mar 2018
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Alexandra A Carrico, Charles L Zhou
Inspected site
IBIndiana Botanic Gardens, IncHobart, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.12(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.140(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 16 observations
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