Sichuan Deebio PhaIIDaceutical Co. Ltd.
FDA inspection history in Guan ban, China, 2023 to 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2023: one Form 483; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24One Form 483 and one warning letter, at Guan ban, China.
Cited most
Across all Sichuan Deebio PhaIIDaceutical Co. observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Sichuan Deebio PhaIIDaceutical 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
Guan ban, China
One Form 483 · 2023 · 6 observations
Latest: Form 483, Sep 8, 2023 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-05 | Warning letter Warning letter | — | — | $99 |
| 2023-09-08 | 483 Form 483 | Guan ban, China | 6 | $99 |
Investigators on these documents
FEI number 3011139911 · most recent document Feb 5, 2024
About Sichuan Deebio PhaIIDaceutical Co. Ltd.
How many FDA Form 483s has Sichuan Deebio PhaIIDaceutical Co. Ltd. received?
FDA Intel has 1 Form 483 on file for Sichuan Deebio PhaIIDaceutical Co. Ltd.; the most recent is dated Sep 8, 2023.
When was Sichuan Deebio PhaIIDaceutical Co. Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Sichuan Deebio PhaIIDaceutical Co. Ltd. is a Form 483 dated Sep 8, 2023, for the site in Guan ban, China.
What did FDA cite at Sichuan Deebio PhaIIDaceutical Co. Ltd.?
The regulations cited most in the observations on file for Sichuan Deebio PhaIIDaceutical Co. Ltd. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.
Has Sichuan Deebio PhaIIDaceutical Co. Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sichuan Deebio PhaIIDaceutical Co. Ltd.; the most recent is dated Feb 5, 2024.