Changzhou Sunlight Pharmaceutical Co. Ltd.
Form 483 issued May 31, 2024 · Changzhou, China
- Inspection
- May 27 – May 31, 2024
- Investigators
- Kshitij A. Patkar· Robin P. Mathew
- Observations
- 1
- Pages
- 1
- FEI number
- 3003662818
In short: On May 31, 2024, FDA issued a Form 483 with 1 observation to Changzhou Sunlight Pharmaceutical Co. Ltd. in Changzhou, Jiangsu (FEI 3003662818) after an inspection that ran May 27 – May 31, 2024. The investigators were Kshitij A. Patkar and Robin P. Mathew. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacturing of API(active pharmaceutical ingredient) intermediates is not operating at the| appropriate…
This inspection in context
Kshitij A. Patkar
1 document · 2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmChangzhou Sunlight Pharmaceutical Co. Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Changzhou Sunlight Pharmaceutical Co. Ltd.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Changzhou Sunlight Pharmaceutical Co. Ltd.?
Kshitij A. Patkar and Robin P. Mathew are named on this Form 483, for the inspection of May 27 – May 31, 2024. Each investigator has a profile showing what they cite most.
When was Changzhou Sunlight Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran May 27 – May 31, 2024, and the Form 483 is dated May 31, 2024.
How do I get the full Form 483 for Changzhou Sunlight Pharmaceutical 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.