SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD
Form 483 issued August 30, 2024 · Shantou, China
- Observations
- 8
- Pages
- 5
- FEI number
- 3016787260
In short: On August 30, 2024, FDA issued a Form 483 with 8 observations to SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD in Shantou, Guangdong (FEI 3016787260). Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Laboratory controls and materials account for 5 of 8 observations.
Most cited: 21 CFR 211.84 (2×) · 211.180 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each component is not tested for conformity with all appropriate written specifications for…
- 02
The identity of each component of a drug product is not verified by conducted at least…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
There shall be a written testing program designed to assess the stability characteristics of drug products…
This inspection in context
Questions about this 483
What did FDA find at SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
When was SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD inspected by FDA?
This Form 483 is dated August 30, 2024.
How do I get the full Form 483 for SHANTOU S.E.Z BAOJIE INDUSTRY 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.