FDA Inspection
APL Healthcare LimitedAPL Healthcare Limited – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns APL Healthcare Limited, with an inspection on December 21, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 7a784fbe-2427-4407-9ac0-e22cd4bf1c8f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075495
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of APL Healthcare Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2023 | Not classified | Office of Inspections and Investigations | |
| January 18, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 31, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for APL Healthcare Limited
- FDA Inspection 1225761 - 2023-11-17
- FDA Inspection 1196972 - 2023-01-18
- FDA Inspection 1012606 - 2017-03-31
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