Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2011-08-31.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Aug 2011 | Not recorded | 483 | View 483 → |
| 15 Oct 2010 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Aug 2011
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Philip Kreiter, Megan A Haggerty
31 Aug 2011
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Philip Kreiter, Megan A Haggerty
31 Aug 2011
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Philip Kreiter, Megan A Haggerty
31 Aug 2011
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Philip Kreiter, Megan A Haggerty
31 Aug 2011
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Philip Kreiter, Megan A Haggerty
Investigators
FDA investigators tied to this site in the record.
Philip Kreiter1 insp.
Megan A Haggerty1 insp.
Robert J Martin1 insp.
Margaret E Walsh1 insp.
Ramon E Martinez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Formatech Inc.'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