Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-06-25.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 May 2019 – 25 Jun 2019 | Human Drugs | WL | View 483 → |
| 6 May 2019 – 20 Jun 2019 | Human Drugs | Clean | |
| 6 May 2019 – 16 May 2019 | Human Drugs | Clean | |
| 15 May 2017 – 1 Jun 2017 | Human Drugs | 483 | View 483 → |
| 9 Apr 2014 – 23 Apr 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Jose O Hernandez3 insp.
Kevin J Flessa3 insp.
Chad N Thompson1 insp.
Robert C Horan1 insp.
Demitria J Xiradakis1 insp.
James A Liubicich1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(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 211.166(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 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | 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 |
| FDCA 503B(b)(2)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Infusion Options, Inc.'s 3 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat