FDA Inspection
Legacy Pharmaceutical Packaging LLCLegacy Pharmaceutical Packaging LLC – FDA Inspection, Jun 20, 2023
Record Details
This FDA Inspection record concerns Legacy Pharmaceutical Packaging LLC, with an inspection on June 20, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8f48f781-195d-41df-95d3-68df44d49411
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1208390
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
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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 30, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1210234 - 2023-06-30
- FDA Inspection 1169547 - 2022-04-27
- FDA Inspection 1115769 - 2020-01-16
- FDA Inspection 1077095 - 2019-01-25
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