Company
ChinaSunshine Lake Pharma Co., Ltd, Dongguan, China – FDA Inspections
Inspection records and compliance data for Sunshine Lake Pharma Co., Ltd in Dongguan. 8 FDA inspections on record (1 OAI), 3 Form 483s, last inspected March 22, 2024.
Company Profile
This profile covers Sunshine Lake Pharma Co., Ltd based in Dongguan, China.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 4
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected April 21, 2011. Last inspected March 22, 2024.
Most cited issue areas
- Cleaning System1 inspection
- Procedures not in writing, fully followed1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 22, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1236240 |
| August 9, 2019 | Not classified | Human Drugs | 1106395 |
| January 25, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1078090 |
| March 16, 2018 | Not classified | Human Drugs | 1046748 |
| October 19, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1030492 |
| September 25, 2015 | OAI | Human Drugs · Drug Quality Assurance | 945450 |
| March 14, 2014 | NAI | Human Drugs · Drug Quality Assurance | 873865 |
| April 21, 2011 | VAI | Human Drugs · Drug Quality Assurance | 728683 |
FDA documents
Form 483s (1)
People (2)
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Company Information
Name
Sunshine Lake Pharma Co., Ltd
FEI Number
3007721552
Address
Northern Industry Road #1, Song Shan Lake, Dongguan, China
Country
China
ID: f256b8e6-f6d3-4011-8a94-3fdb7ffcb363