Zhejiang Dingtai Pharmaceutical Co., Ltd
Form 483 issued January 25, 2019 · Tongxiang, China
- Inspection
- Jan 21 – Jan 25, 2019
- Investigator
- Kara D. Dobbin
- Observations
- 4
- Pages
- 4
- FEI number
- 3011302639
In short: On January 25, 2019, FDA issued a Form 483 with 4 observations to Zhejiang Dingtai Pharmaceutical Co., Ltd in Tongxiang, Zhejiang (FEI 3011302639) after an inspection that ran Jan 21 – Jan 25, 2019. The investigator was Kara D. Dobbin. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans, and…
- 02
The batch production and control records are deficient in that they do not include documentation of…
- 03
Drug product production and control records are not uniquely…
- 04
Batch production records did not include all calculations performed during the manufacturing, processing, or holding of…
This inspection in context
Kara D. Dobbin
5 documents · 2017–2020
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in China.
The firmZhejiang Dingtai Pharmaceutical Co., Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Dingtai Pharmaceutical Co., Ltd?
FDA listed 4 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Zhejiang Dingtai Pharmaceutical Co., Ltd?
Kara D. Dobbin is named on this Form 483, for the inspection of Jan 21 – Jan 25, 2019. Each investigator has a profile showing what they cite most.
When was Zhejiang Dingtai Pharmaceutical Co., Ltd inspected by FDA?
The inspection ran Jan 21 – Jan 25, 2019, and the Form 483 is dated January 25, 2019.
How do I get the full Form 483 for Zhejiang Dingtai 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.