Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-18.
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 |
|---|---|---|---|
| 15 Apr 2024 – 18 Apr 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Apr 2018 – 26 Apr 2018 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Apr 2024
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Jacqueline S Warner
18 Apr 2024
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Jacqueline S Warner
26 Apr 2018
21 CFR 820.40
Procedures not adequately established or maintained
Cited by James D Hildreth
26 Apr 2018
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by James D Hildreth
Investigators
FDA investigators tied to this site in the record.
Jacqueline S Warner1 insp.
James D Hildreth1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PB-Kunststoffverarbeitung ballerstedt Gmbh's 2 Form 483s
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