Overview
- 18 FDA inspections are on record.
- 16 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-29.
At a glance
Inspections
18
Form 483s
16
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Feb 2024 – 29 Feb 2024 | Human Drugs | 483 | On file |
| 21 Jun 2023 – 30 Jun 2023 | Human Drugs | 483 | View 483 → |
| 21 Jun 2023 – 30 Jun 2023 | Human Drugs | 483 | View 483 → |
| 21 Jun 2023 – 30 Jun 2023 | Human Drugs | 483 | View 483 → |
| 12 Jun 2023 – 20 Jun 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Apr 2022 – 27 Apr 2022 | Human Drugs | WL | On file |
| 13 Jan 2020 – 16 Jan 2020 | Medical Devices & Rad Health | 483 | On file |
| 16 Jan 2019 – 25 Jan 2019 | Human Drugs | 483 | View 483 → |
| 22 May 2017 – 26 May 2017 | Human Drugs | 483 | View 483 → |
| 22 Jun 2015 – 9 Jul 2015 | Human Drugs | 483 | View 483 → |
| 29 Jul 2014 – 29 Aug 2014 | Human Drugs | 483 | View 483 → |
| 14 Nov 2013 – 26 Nov 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Jun 2023
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Gretchen L Trendel, Joseph A Piechocki, Mary L Schuckmann
30 Jun 2023
21 CFR 211.130(e)
Packaging line inspection before use
Cited by Gretchen L Trendel, Joseph A Piechocki, Mary L Schuckmann
30 Jun 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Gretchen L Trendel, Joseph A Piechocki, Mary L Schuckmann
30 Jun 2023
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Gretchen L Trendel, Joseph A Piechocki, Mary L Schuckmann
30 Jun 2023
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Gretchen L Trendel, Joseph A Piechocki, Mary L Schuckmann
Investigators
FDA investigators tied to this site in the record.
Mary L Schuckmann4 insp.
Robert J Ham3 insp.
Gretchen L Trendel3 insp.
Joseph A Piechocki3 insp.
Edward E Lockwood2 insp.
Michele L Obert2 insp.
Dawn C Olenjack2 insp.
Anthony Bucks2 insp.
Matthew M Schuckmann1 insp.
Ana Paula P Sandee1 insp.
Tiara N Brown-Crosen1 insp.
Adree N Anderson1 insp.
Sherry G Bous1 insp.
David L Miser1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.89 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Legacy Pharmaceutical Packaging, LLC's 16 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