FDA Inspection
Legacy Pharmaceutical Packaging LLCLegacy Pharmaceutical Packaging LLC – FDA Inspection, Jul 9, 2015
Record Details
This FDA Inspection record concerns Legacy Pharmaceutical Packaging LLC, with an inspection on July 9, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 9, 2015
- Product Type
- Drugs
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ID · e8c3a0eb-1e68-47d6-8561-8ad70fe6aaa0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 933826
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.110(b)In-process materials specifications
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.182Chronological Order of Equipment Log Entries
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192Written record of investigation incomplete
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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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