Chongqing Kangle Pharmaceutical Co., Ltd.
Form 483 issued July 26, 2018 · Chongqing, China
- Observations
- 1
- Pages
- 1
- FEI number
- 3007088564
In short: On July 26, 2018, FDA issued a Form 483 with 1 observation to Chongqing Kangle Pharmaceutical Co., Ltd. in Chongqing, China (FEI 3007088564). Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.46 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Material System) Equipment for adequate control over temperature and humidity is not provided when appropriate for…
This inspection in context
Questions about this 483
What did FDA find at Chongqing Kangle Pharmaceutical Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
When was Chongqing Kangle Pharmaceutical Co., Ltd. inspected by FDA?
This Form 483 is dated July 26, 2018.
How do I get the full Form 483 for Chongqing Kangle 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.