FDA Inspection
Legacy Pharmaceutical Packaging LLCLegacy Pharmaceutical Packaging LLC – FDA Inspection, Jun 30, 2023
Record Details
This FDA Inspection record concerns Legacy Pharmaceutical Packaging LLC, with an inspection on June 30, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · beb7b7e6-17d9-4af2-9e3b-17aa2210d920
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1210234
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.25(a)Training , Education , Experience overall
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Legacy Pharmaceutical Packaging LLC
14| Date | Classification | Office | Project area |
|---|---|---|---|
| February 29, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 20, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 27, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 16, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 25, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Legacy Pharmaceutical Packaging LLC
- FDA Inspection 1229505 - 2024-02-29
- FDA Inspection 1208390 - 2023-06-20
- FDA Inspection 1169547 - 2022-04-27
- FDA Inspection 1115769 - 2020-01-16
- FDA Inspection 1077095 - 2019-01-25
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.