Qingdao Kangyuan Pharmaceutical Co., Ltd
Form 483 issued August 16, 2024 · Jiaozhou City, China
- Inspection
- Aug 12 – Aug 16, 2024
- Investigator
- Alan A. Rivera
- Observations
- 4
- Pages
- 4
- FEI number
- 3006512854
In short: On August 16, 2024, FDA issued a Form 483 with 4 observations to Qingdao Kangyuan Pharmaceutical Co., Ltd in Jiaozhou City, Shandong (FEI 3006512854) after an inspection that ran Aug 12 – Aug 16, 2024. The investigator was Alan A. Rivera. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include scientifically sound and appropriate specifications, sampling plans and test procedures designed…
- 02
The master batch production record lacks an established time limit and detailed production instructions to ensure…
- 03
Failure to validate and verify the…
- 04
Equipment used in the manufacture of intermediates and API’s should be maintained in a good state…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmQingdao Kangyuan Pharmaceutical Co., Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Qingdao Kangyuan Pharmaceutical Co., Ltd?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Qingdao Kangyuan Pharmaceutical Co., Ltd?
Alan A. Rivera is named on this Form 483, for the inspection of Aug 12 – Aug 16, 2024. Each investigator has a profile showing what they cite most.
When was Qingdao Kangyuan Pharmaceutical Co., Ltd inspected by FDA?
The inspection ran Aug 12 – Aug 16, 2024, and the Form 483 is dated August 16, 2024.
How do I get the full Form 483 for Qingdao Kangyuan 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.