Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-09-11.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Aug 2013 – 11 Sep 2013 | Human Drugs | 483 | View 483 → |
| 1 Aug 2008 | Not recorded | 483 | On file |
| 10 Aug 2006 | Not recorded | Clean | |
| 19 Jul 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Sep 2013
21 CFR 111.315
Laboratory control processes - requirements
Cited by Gayle S Lawson, Stephen J Koniers
11 Sep 2013
21 CFR 111.415(a)
Clean, sanitize - filling, packaging equipment
Cited by Gayle S Lawson, Stephen J Koniers
11 Sep 2013
21 CFR 211.22(b)
Adequate lab facilities not available
Cited by Gayle S Lawson, Stephen J Koniers
11 Sep 2013
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Gayle S Lawson, Stephen J Koniers
11 Sep 2013
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Gayle S Lawson, Stephen J Koniers
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.315 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Purdy-Pak, Inc. dba Tite-Pak & PPI's 2 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