SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD
FDA inspection history in Shantou, China, 2024 to 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2024–25One Form 483 and one warning letter, at Shantou, China.
Cited most
Across all SHANTOU S.E.Z BAOJIE INDUSTRY CO. observations on file
- 21 CFR 211.180General requirements2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.166Stability testing1
- 21 CFR 211.170Reserve samples1
- 21 CFR 211.194Laboratory records1
The complete SHANTOU S.E.Z BAOJIE INDUSTRY CO. file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Shantou, China
One warning letter and one Form 483 · 2024 to 2025
Latest: Warning letter, Apr 15, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-15 | Warning letter Warning letter | Shantou, China | — | $99 |
| 2024-08-30 | 483 Form 483 | Shantou, China | — | $99 |
FEI number 3016787260 · most recent document Apr 15, 2025
About SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD
How many FDA Form 483s has SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD received?
FDA Intel has 1 Form 483 on file for SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD; the most recent is dated Aug 30, 2024.
When was SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD last inspected by FDA?
The most recent FDA inspection document on file for SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD is a Form 483 dated Aug 30, 2024, for the site in Shantou, China.
What did FDA cite at SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD?
The regulations cited most in the observations on file for SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD are 21 CFR 211.180 (General requirements), 2 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.166 (Stability testing), 1 time.
Has SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD; the most recent is dated Apr 15, 2025.