Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-02-09.
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 |
|---|---|---|---|
| 6 Feb 2017 – 9 Feb 2017 | Human Drugs | 483 | On file |
| 7 Apr 2014 – 11 Apr 2014 | Human Drugs | 483 | View 483 → |
| 13 Apr 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Apr 2012
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Susan D Yuscius, Pal S Mayasandra
13 Apr 2012
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Susan D Yuscius, Pal S Mayasandra
13 Apr 2012
21 CFR 211.192
Written record of investigation incomplete
Cited by Susan D Yuscius, Pal S Mayasandra
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez1 insp.
Rosa J Motta1 insp.
Laurie B Frazier1 insp.
Susan D Yuscius1 insp.
Pal S Mayasandra1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Arrow Pharm Limited'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