Sunshine Lake Pharma Co., Ltd.
Form 483 issued March 22, 2024 · Dongguan, China
- Inspection
- Mar 18 – Mar 22, 2024
- Investigator
- Ephrem Huaibe
- Observations
- 1
- Pages
- 2
- FEI number
- 3007721552
In short: On March 22, 2024, FDA issued a Form 483 with 1 observation to Sunshine Lake Pharma Co., Ltd. in Dongguan, Guangdong (FEI 3007721552) after an inspection that ran Mar 18 – Mar 22, 2024. The investigator was Ephrem Huaibe. Most observations concern quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.180 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed for evaluations done at least annually and including provisions for a…
This inspection in context
Ephrem Huaibe
1 document · 2024
Cites 211.180 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmSunshine Lake Pharma Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sunshine Lake Pharma Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Sunshine Lake Pharma Co., Ltd.?
Ephrem Huaibe is named on this Form 483, for the inspection of Mar 18 – Mar 22, 2024. Each investigator has a profile showing what they cite most.
When was Sunshine Lake Pharma Co., Ltd. inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2024, and the Form 483 is dated March 22, 2024.
How do I get the full Form 483 for Sunshine Lake Pharma Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.