Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-05-29.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Apr 2019 – 29 May 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 May 2017 – 19 Jun 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Mar 2013 – 3 Apr 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Nov 2012 | Not recorded | 483 | On file |
| 27 Feb 2012 | Not recorded | 483 | View 483 → |
| 16 May 2011 | Not recorded | 483 | View 483 → |
| 21 Nov 2006 | Not recorded | Clean | |
| 30 Jul 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 May 2019
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Gobiga Vanniyasingam, Phillip M Pontikos, Melissa A Zuppe
29 May 2019
21 CFR 820.181
DMR - not or inadequately maintained
Cited by Gobiga Vanniyasingam, Phillip M Pontikos, Melissa A Zuppe
29 May 2019
21 CFR 820.184
DHR - not or inadequately maintained
Cited by Gobiga Vanniyasingam, Phillip M Pontikos, Melissa A Zuppe
29 May 2019
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Gobiga Vanniyasingam, Phillip M Pontikos, Melissa A Zuppe
29 May 2019
21 CFR 820.30(j)
Design history file
Cited by Gobiga Vanniyasingam, Phillip M Pontikos, Melissa A Zuppe
Investigators
FDA investigators tied to this site in the record.
Phillip M Pontikos2 insp.
Eric J Cunningham2 insp.
Loretta Nemchik2 insp.
Gobiga Vanniyasingam1 insp.
Melissa A Zuppe1 insp.
Alberto A Viciedo1 insp.
Amy M Cramer1 insp.
Dennis E Guilfoyle1 insp.
Miguel G Manzano1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pharmaceutical Innovations, Inc.'s 6 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