Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-09-08.
At a glance
Inspections
3
Form 483s
1
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Aug 2017 – 8 Sep 2017 | Human Drugs | Clean | |
| 8 Aug 2016 – 11 Aug 2016 | Human Drugs | Clean | |
| 18 Mar 2013 – 1 Apr 2013 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Apr 2013
21 CFR 211.28(a)
Clothing appropriate for duties performed
Cited by Anita R Michael, Julianne C Mccullough
1 Apr 2013
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Anita R Michael, Julianne C Mccullough
1 Apr 2013
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Anita R Michael, Julianne C Mccullough
1 Apr 2013
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Anita R Michael, Julianne C Mccullough
1 Apr 2013
21 CFR 211.80(a)
Procedures To Be in Writing
Cited by Anita R Michael, Julianne C Mccullough
Investigators
FDA investigators tied to this site in the record.
Russell J Glapion1 insp.
Philip F Istafanos1 insp.
Clifton L Randell1 insp.
Thomas E Friel1 insp.
Anita R Michael1 insp.
Julianne C Mccullough1 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 | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pentec Health's 1 Form 483
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