FDA Intel

Lights Medical Manufacture Co., Lid No. (9 Quanda Road, Wuging Development Area

FDA inspection history in Tianjin, China, 2024

1
Form 483

Every document, by year

  • Form 483

2024: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2024One Form 483, at Tianjin, China.

Cited most

Across all Lights Medical Manufacture Co., Lid No. (9 Quanda Road, Wuging Development Area observations on file

The complete Lights Medical Manufacture Co., Lid No. (9 Quanda Road, Wuging Development Area file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2024-11-08483 Form 483$99

Investigators on these documents

Tonia F. Bernard (1)

About Lights Medical Manufacture Co., Lid No. (9 Quanda Road, Wuging Development Area

How many FDA Form 483s has Lights Medical Manufacture Co., Lid No. (9 Quanda Road, Wuging Development Area received?

FDA Intel has 1 Form 483 on file for Lights Medical Manufacture Co., Lid No. (9 Quanda Road, Wuging Development Area; the most recent is dated Nov 8, 2024.

When was Lights Medical Manufacture Co., Lid No. (9 Quanda Road, Wuging Development Area last inspected by FDA?

The most recent FDA inspection document on file for Lights Medical Manufacture Co., Lid No. (9 Quanda Road, Wuging Development Area is a Form 483 dated Nov 8, 2024, for the site in Tianjin, China.

What did FDA cite at Lights Medical Manufacture Co., Lid No. (9 Quanda Road, Wuging Development Area?

The regulations cited most in the observations on file for Lights Medical Manufacture Co., Lid No. (9 Quanda Road, Wuging Development Area are 21 CFR 211.182 (Equipment cleaning and use log), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.