Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-07-28.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jul 2017 – 28 Jul 2017 | Human Drugs | 483 | On file |
| 25 Jan 2016 – 5 Feb 2016 | Human Drugs | 483 | View 483 → |
| 14 Jul 2014 – 22 Jul 2014 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Feb 2016
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Massoud Motamed, Shelby N Marler
5 Feb 2016
21 CFR 211.42(c)(10)(vi)
Equipment to control conditions
Cited by Massoud Motamed, Shelby N Marler
5 Feb 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Massoud Motamed, Shelby N Marler
5 Feb 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Massoud Motamed, Shelby N Marler
5 Feb 2016
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Massoud Motamed, Shelby N Marler
Investigators
FDA investigators tied to this site in the record.
Scott T Ballard1 insp.
Nimmy Mathews1 insp.
Massoud Motamed1 insp.
Shelby N Marler1 insp.
Lucas B Leake1 insp.
Sharon K Thoma1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind I.V. Specialty, Ltd'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