Guang’an Kingday Pharma & Chem Co., Ltd.
Form 483 issued May 24, 2024 · Guangan, China
- Observations
- 3
- Pages
- 3
- FEI number
- 3009846816
In short: On May 24, 2024, FDA issued a Form 483 with 3 observations to Guang’an Kingday Pharma & Chem Co., Ltd. in Guangan, Sichuan (FEI 3009846816). Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controis do not include scientifically sound and appropriate specifications, sampling plans and test procedures designed…
- 02
Specifically, Your firm failed to have GMP related computerized systems validated. As explained by your firm's…
- 03
Cleaning procedures have not been monitored at appropriate intervals after validation to ensure that these procedures…
This inspection in context
Questions about this 483
What did FDA find at Guang’an Kingday Pharma & Chem Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Guang’an Kingday Pharma & Chem Co., Ltd. inspected by FDA?
This Form 483 is dated May 24, 2024.
How do I get the full Form 483 for Guang’an Kingday Pharma & Chem 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.