Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Form 483 issued January 14, 2021 · Lianyungang, China
- Inspection
- Jan 6 – Jan 14, 2021
- Investigator
- Marijo B. Kambere
- Observations
- 1
- Pages
- 1
- FEI number
- 3011860409
In short: On January 14, 2021, FDA issued a Form 483 with 1 observation to Chia Tai Tianqing Pharmaceutical Group Co., Ltd. in Lianyungang, Jiangsu (FEI 3011860409) after an inspection that ran Jan 6 – Jan 14, 2021. The investigator was Marijo B. Kambere. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in writing…
This inspection in context
Marijo B. Kambere
11 documents · 2015–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmChia Tai Tianqing Pharmaceutical Group Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chia Tai Tianqing Pharmaceutical Group Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about quality system. 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.
Who inspected Chia Tai Tianqing Pharmaceutical Group Co., Ltd.?
Marijo B. Kambere is named on this Form 483, for the inspection of Jan 6 – Jan 14, 2021. Each investigator has a profile showing what they cite most.
When was Chia Tai Tianqing Pharmaceutical Group Co., Ltd. inspected by FDA?
The inspection ran Jan 6 – Jan 14, 2021, and the Form 483 is dated January 14, 2021.
How do I get the full Form 483 for Chia Tai Tianqing Pharmaceutical Group 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.