Taizhou Xianju Pharmaceutical Co. Ltd.
Form 483 issued March 31, 2017 · Taizhou, China
- Inspection
- Mar 27 – Mar 31, 2017
- Investigator
- Tajah L. Blackburn
- Observations
- 3
- Pages
- 3
- FEI number
- 3012045665
In short: On March 31, 2017, FDA issued a Form 483 with 3 observations to Taizhou Xianju Pharmaceutical Co. Ltd. in Taizhou, Zhejiang (FEI 3012045665) after an inspection that ran Mar 27 – Mar 31, 2017. The investigator was Tajah L. Blackburn. Most observations concern packaging & labeling and facilities & equipment; the most-cited regulation is 21 CFR 211.130 (packaging and labeling operations).
At a glance
Packaging & labeling and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality unit failed to follow procedures for the review of product…
- 02
The firm failed to implement written procedures…
- 03
Warehousing procedures failed ta…
This inspection in context
Tajah L. Blackburn
7 documents · 2015–2020
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Maryland.
The firmTaizhou Xianju Pharmaceutical Co. Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.130
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Taizhou Xianju Pharmaceutical Co. Ltd.?
FDA listed 3 observations on this Form 483, mostly about packaging & labeling, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.130 (packaging and labeling operations). The opening words of each observation are shown on this page.
Who inspected Taizhou Xianju Pharmaceutical Co. Ltd.?
Tajah L. Blackburn is named on this Form 483, for the inspection of Mar 27 – Mar 31, 2017. Each investigator has a profile showing what they cite most.
When was Taizhou Xianju Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran Mar 27 – Mar 31, 2017, and the Form 483 is dated March 31, 2017.
How do I get the full Form 483 for Taizhou Xianju Pharmaceutical Co. Ltd.?
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