CSPC Ouyi Pharmaceutical Co., Ltd.
Form 483 issued May 17, 2019 · Shijiazhuang, China
- Inspection
- May 13 – May 17, 2019
- Observations
- 1
- Pages
- 1
- FEI number
- 2000021110
In short: On May 17, 2019, FDA issued a Form 483 with 1 observation to CSPC Ouyi Pharmaceutical Co., Ltd. in Shijiazhuang, Hebei (FEI 2000021110) after an inspection that ran May 13 – May 17, 2019. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your examination and testing of samples did not assure that the drug product and in-process…
This inspection in context
Questions about this 483
What did FDA find at CSPC Ouyi Pharmaceutical Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about 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 CSPC Ouyi Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran May 13 – May 17, 2019, and the Form 483 is dated May 17, 2019.
How do I get the full Form 483 for CSPC Ouyi 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.