FDA Inspection
Legacy Pharmaceutical Packaging LLCLegacy Pharmaceutical Packaging LLC – FDA Inspection, Jun 18, 2013
Record Details
This FDA Inspection record concerns Legacy Pharmaceutical Packaging LLC, with an inspection on June 18, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 18, 2013
- Product Type
- Drugs
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ID · 2623eaca-d438-4839-b019-abc02452f969
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 835583
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| 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 |
Other documents for Legacy Pharmaceutical Packaging LLC
- FDA Inspection 1229505 - 2024-02-29
- FDA Inspection 1210234 - 2023-06-30
- FDA Inspection 1208390 - 2023-06-20
- FDA Inspection 1169547 - 2022-04-27
- FDA Inspection 1115769 - 2020-01-16
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