Xiamen LP Pharmaceutical Co., Ltd.
Form 483 issued March 4, 2022 · Xiamen, China
- Inspection
- Feb 28 – Mar 4, 2022
- Investigator
- Tonia F. Bernard
- Observations
- 2
- Pages
- 1
- FEI number
- 3013002864
In short: On March 4, 2022, FDA issued a Form 483 with 2 observations to Xiamen LP Pharmaceutical Co., Ltd. in Xiamen, Fujian (FEI 3013002864) after an inspection that ran Feb 28 – Mar 4, 2022. The investigator was Tonia F. Bernard. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures applicable to equipment…
- 02
Your supplier’s management program is deficient to ensure a…
This inspection in context
Tonia F. Bernard
13 documents · 2016–2024
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmXiamen LP 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 Xiamen LP Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about 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 Xiamen LP Pharmaceutical Co., Ltd.?
Tonia F. Bernard is named on this Form 483, for the inspection of Feb 28 – Mar 4, 2022. Each investigator has a profile showing what they cite most.
When was Xiamen LP Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Feb 28 – Mar 4, 2022, and the Form 483 is dated March 4, 2022.
How do I get the full Form 483 for Xiamen LP 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.