Chongqing Daxin Pharmaceutical Co., Ltd.
Form 483 issued May 11, 2018 · Chongqing, China
- Inspection
- May 8 – May 11, 2018
- Observations
- 4
- Pages
- 1
- FEI number
- 3000291692
In short: On May 11, 2018, FDA issued a Form 483 with 4 observations to Chongqing Daxin Pharmaceutical Co., Ltd. in Chongqing, Chongqing (FEI 3000291692) after an inspection that ran May 8 – May 11, 2018. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls 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
i er were optimized in 2017 which involved updates to…
- 02
The process validation SOP, V (gl) -002-18.0, section 5.3. indicates that worst-case parameters should be used…
- 03
The microbiological identification procedure, QC (qt) -024-17.0, section 2, specifies that microbiological identification will be…
- 04
The clean area touch plate monitoring management procedure, QC (jj) -007-14.0, section 10.9, specifies that an…
This inspection in context
Questions about this 483
What did FDA find at Chongqing Daxin Pharmaceutical Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.
When was Chongqing Daxin Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran May 8 – May 11, 2018, and the Form 483 is dated May 11, 2018.
How do I get the full Form 483 for Chongqing Daxin 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.