Jiangsu Baozong & Baoda Pharmachem Co., Ltd.
Form 483 issued June 21, 2019 · Rugao, China
- Inspection
- Jun 18 – Jun 21, 2019
- Investigator
- Joel D. Hustedt
- Observations
- 5
- Pages
- 5
- FEI number
- 3009160668
In short: On June 21, 2019, FDA issued a Form 483 with 5 observations to Jiangsu Baozong & Baoda Pharmachem Co., Ltd. in Rugao, Jiangsu (FEI 3009160668) after an inspection that ran Jun 18 – Jun 21, 2019. The investigator was Joel D. Hustedt. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 3 of 5 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(b) (4) pe PaKey ° : Waitten procedures for cleaning of and for verifying the cleanliness…
- 02
Critical processing parameters for the manufacture of? API have…
- 03
Procedures applicable to the quality unit are inadequate…
- 04
a) Your firm’s QC Manager had a notebook containing lists with several user names and passwords…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmJiangsu Baozong & Baoda Pharmachem Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jiangsu Baozong & Baoda Pharmachem Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Jiangsu Baozong & Baoda Pharmachem Co., Ltd.?
Joel D. Hustedt is named on this Form 483, for the inspection of Jun 18 – Jun 21, 2019. Each investigator has a profile showing what they cite most.
When was Jiangsu Baozong & Baoda Pharmachem Co., Ltd. inspected by FDA?
The inspection ran Jun 18 – Jun 21, 2019, and the Form 483 is dated June 21, 2019.
How do I get the full Form 483 for Jiangsu Baozong & Baoda Pharmachem 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.