Overview
- 16 public-safe observations are available for this inspection.
- 15 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.
25 Jun 2019
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Jose O Hernandez, Chad N Thompson, Kevin J Flessa
25 Jun 2019
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jose O Hernandez, Chad N Thompson, Kevin J Flessa
25 Jun 2019
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Jose O Hernandez, Chad N Thompson, Kevin J Flessa
25 Jun 2019
21 CFR 211.160(b)(3)
Drug products - samples representative, identified properly
Cited by Jose O Hernandez, Chad N Thompson, Kevin J Flessa
25 Jun 2019
21 CFR 211.165(a)
Testing and release for distribution
Cited by Jose O Hernandez, Chad N Thompson, Kevin J Flessa
Inspected site
IOInfusion Options, Inc.Brooklyn, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(b)(2)(A) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 16 observations
The full inspection record, as Atlas holds it, 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