FDA Inspection
Legacy Pharmaceutical Packaging LLCLegacy Pharmaceutical Packaging LLC – FDA Inspection, Nov 26, 2013
Record Details
This FDA Inspection record concerns Legacy Pharmaceutical Packaging LLC, with an inspection on November 26, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 26, 2013
- Product Type
- Drugs
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ID · 8cedef5b-f2e7-4da6-b4cd-a4d1a4cc0b73
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857573
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192No written record of investigation
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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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