Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-03-30.
At a glance
Inspections
2
Form 483s
1
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Mar 2022 – 30 Mar 2022 | Human Drugs | 483 | View 483 → |
| 27 Apr 2016 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Mar 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Nicole E Knowlton, Damaris Y Hernandez, Dorothy P Kramer
30 Mar 2022
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Nicole E Knowlton, Damaris Y Hernandez, Dorothy P Kramer
30 Mar 2022
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Nicole E Knowlton, Damaris Y Hernandez, Dorothy P Kramer
30 Mar 2022
21 CFR 211.68(b)
Computer control of master formula records
Cited by Nicole E Knowlton, Damaris Y Hernandez, Dorothy P Kramer
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 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Klocke of America, Inc.'s 1 Form 483
Source PDFs 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