Ningbo Shuangcheng Pharmaceutical Co., Ltd
Form 483 issued November 3, 2023 · Cixi city, China
- Observations
- 2
- Pages
- 2
- FEI number
- 3014148045
In short: On November 3, 2023, FDA issued a Form 483 with 2 observations to Ningbo Shuangcheng Pharmaceutical Co., Ltd in Cixi city, Zhejiang (FEI 3014148045). Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity…
- 02
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Questions about this 483
What did FDA find at Ningbo Shuangcheng Pharmaceutical Co., Ltd?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was Ningbo Shuangcheng Pharmaceutical Co., Ltd inspected by FDA?
This Form 483 is dated November 3, 2023.
How do I get the full Form 483 for Ningbo Shuangcheng 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.