FDA Inspection
Sharp Packaging Services, LLCSharp Packaging Services, LLC – FDA Inspection, Jan 28, 2022
Record Details
This FDA Inspection record concerns Sharp Packaging Services, LLC, with an inspection on January 28, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 28, 2022
- Product Type
- Drugs
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ID · 287ded72-84d1-46c5-9ae3-b9d3013a5cfe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1161256
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.125(d)Destruction of excess labels with lot numbers
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.188(a)Accurate reproduction
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Other FDA inspections of Sharp Packaging Services, LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2026 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| November 21, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 24, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 13, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sharp Packaging Services, LLC
- FDA Inspection 1314200 - 2026-04-22
- FDA Inspection 1283904 - 2025-11-21
- FDA Inspection 1087516 - 2019-04-24
- FDA Inspection 1070357 - 2018-08-13
- FDA Inspection 1002333 - 2017-02-03
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