FDA Inspection
Sunshine Lake Pharma Co., LtdSunshine Lake Pharma Co., Ltd – FDA Inspection, Jan 25, 2019
Record Details
This FDA Inspection record concerns Sunshine Lake Pharma Co., Ltd, with an inspection on January 25, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 64dc7b2e-06c8-40ea-8cbc-8a4f8824f3ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078090
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of Sunshine Lake Pharma Co., Ltd
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 9, 2019 | Not classified | Office of Inspections and Investigations | |
| March 16, 2018 | Not classified | Office of Inspections and Investigations | |
| October 19, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 25, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sunshine Lake Pharma Co., Ltd
- FDA Inspection 1236240 - 2024-03-22
- FDA Inspection 1106395 - 2019-08-09
- FDA Inspection 1046748 - 2018-03-16
- FDA Inspection 1030492 - 2017-10-19
- FDA Inspection 945450 - 2015-09-25
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