Lights Medical Manufacture Co., Ltd
Form 483 issued November 8, 2024 · Tianjin, China
- Inspection
- Nov 4 – Nov 8, 2024
- Investigator
- Tonia F. Bernard
- Observations
- 2
- Pages
- 2
- FEI number
- 3005310494
In short: On November 8, 2024, FDA issued a Form 483 with 2 observations to Lights Medical Manufacture Co., Ltd in Tianjin, Tianjin (FEI 3005310494) after an inspection that ran Nov 4 – Nov 8, 2024. The investigator was Tonia F. Bernard. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.182 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures applicable to the quality unit…
- 02
Written records of major equipment use are not included…
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 firmLights Medical Manufacture Co., Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lights Medical Manufacture Co., Ltd?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Lights Medical Manufacture Co., Ltd?
Tonia F. Bernard is named on this Form 483, for the inspection of Nov 4 – Nov 8, 2024. Each investigator has a profile showing what they cite most.
When was Lights Medical Manufacture Co., Ltd inspected by FDA?
The inspection ran Nov 4 – Nov 8, 2024, and the Form 483 is dated November 8, 2024.
How do I get the full Form 483 for Lights Medical Manufacture 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.