FDA Inspection
APL Healthcare LimitedAPL Healthcare Limited – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns APL Healthcare Limited, with an inspection on March 31, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · dbbb1c91-ecbf-4743-a2f4-aa01b4fffe48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012606
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.111Establishment of time limitations
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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 |
| December 21, 2018 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
Other documents for APL Healthcare Limited
- FDA Inspection 1225761 - 2023-11-17
- FDA Inspection 1196972 - 2023-01-18
- FDA Inspection 1075495 - 2018-12-21
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