Sichuan Deebio PhaIIDaceutical Co. Ltd.
Form 483 issued September 8, 2023 · Guan ban, China
- Inspection
- Sep 4 – Sep 8, 2023
- Investigators
- Anders W. Evenson· Arsen Karapetyan
- Observations
- 6
- Pages
- 6
- FEI number
- 3011139911
In short: On September 8, 2023, FDA issued a Form 483 with 6 observations to Sichuan Deebio PhaIIDaceutical Co. Ltd. in Guan ban, Sichuan (FEI 3011139911) after an inspection that ran Sep 4 – Sep 8, 2023. The investigators were Anders W. Evenson and Arsen Karapetyan. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records are not completed contemporaneously and do not include complete data derived from all tests…
- 02
The quality control unit lacks responsibility to approve all procedures, specifications, or test methods impacting on…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Written records of investigation into unexplained discrepancies and the fai lure of a batch or any…
This inspection in context
Anders W. Evenson
3 documents · 2022–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmSichuan Deebio PhaIIDaceutical Co. Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sichuan Deebio PhaIIDaceutical Co. Ltd.?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Sichuan Deebio PhaIIDaceutical Co. Ltd.?
Anders W. Evenson and Arsen Karapetyan are named on this Form 483, for the inspection of Sep 4 – Sep 8, 2023. Each investigator has a profile showing what they cite most.
When was Sichuan Deebio PhaIIDaceutical Co. Ltd. inspected by FDA?
The inspection ran Sep 4 – Sep 8, 2023, and the Form 483 is dated September 8, 2023.
How do I get the full Form 483 for Sichuan Deebio PhaIIDaceutical 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.