Zhejiang Cheng Yi Pharmaceutical Co., Ltd.
Form 483 issued November 22, 2019 · Wenzhou City, China
- Inspection
- Nov 18 – Nov 22, 2019
- Investigator
- Santos E. Camara
- Observations
- 4
- Pages
- 3
- FEI number
- 3004090742
In short: On November 22, 2019, FDA issued a Form 483 with 4 observations to Zhejiang Cheng Yi Pharmaceutical Co., Ltd. in Wenzhou City, Zhejiang (FEI 3004090742) after an inspection that ran Nov 18 – Nov 22, 2019. The investigator was Santos E. Camara. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to review production records to assure that no errors have…
- 02
Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmZhejiang Cheng Yi Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Cheng Yi Pharmaceutical Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about production, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Zhejiang Cheng Yi Pharmaceutical Co., Ltd.?
Santos E. Camara is named on this Form 483, for the inspection of Nov 18 – Nov 22, 2019. Each investigator has a profile showing what they cite most.
When was Zhejiang Cheng Yi Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Nov 18 – Nov 22, 2019, and the Form 483 is dated November 22, 2019.
How do I get the full Form 483 for Zhejiang Cheng Yi 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.