Shandong Luxi Pharmaceutical Co., Ltd.
Form 483 issued July 24, 2019 · Heze, China
- Inspection
- Jul 18 – Jul 24, 2019
- Investigator
- Rumany C. Penn
- Observations
- 6
- Pages
- 3
- FEI number
- 3011615110
In short: On July 24, 2019, FDA issued a Form 483 with 6 observations to Shandong Luxi Pharmaceutical Co., Ltd. in Heze, Shandong (FEI 3011615110) after an inspection that ran Jul 18 – Jul 24, 2019. The investigator was Rumany C. Penn. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Laboratory controls and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 211.68 (3×) · 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Stability studies are insutficient…
- 02
Laboratory records and raw data records…
- 03
Laboratory control procedures are…
- 04
Laboratory procedures are not…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmShandong Luxi Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shandong Luxi Pharmaceutical Co., Ltd.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Shandong Luxi Pharmaceutical Co., Ltd.?
Rumany C. Penn is named on this Form 483, for the inspection of Jul 18 – Jul 24, 2019. Each investigator has a profile showing what they cite most.
When was Shandong Luxi Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jul 18 – Jul 24, 2019, and the Form 483 is dated July 24, 2019.
How do I get the full Form 483 for Shandong Luxi Pharmaceutical Co., Ltd.?
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