Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2016-09-15.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Sep 2016 – 15 Sep 2016 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Sep 2016
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Lillie D Witcher, Kara D Dobbin, Jawaid Hamid
15 Sep 2016
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Lillie D Witcher, Kara D Dobbin, Jawaid Hamid
15 Sep 2016
21 CFR 211.194(a)(4)
Complete Test Data
Cited by Lillie D Witcher, Kara D Dobbin, Jawaid Hamid
15 Sep 2016
21 CFR 211.22(a)
Lack of quality control unit
Cited by Lillie D Witcher, Kara D Dobbin, Jawaid Hamid
15 Sep 2016
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Lillie D Witcher, Kara D Dobbin, Jawaid Hamid
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 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PDQ Manufacturing Inc's 1 Form 483
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