FDA Inspection
Legacy Pharmaceutical Packaging LLCLegacy Pharmaceutical Packaging LLC – FDA Inspection, Aug 29, 2014
Record Details
This FDA Inspection record concerns Legacy Pharmaceutical Packaging LLC, with an inspection on August 29, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 29, 2014
- Product Type
- Drugs
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ID · 5276b08a-7742-4b11-b170-1cb2e68cf15a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 890208
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 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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