BrightGene Fine Chemical Co., Ltd.
Form 483 issued January 20, 2024 · Taizhou, China
- Observations
- 5
- Pages
- 8
- FEI number
- 3011254184
In short: On January 20, 2024, FDA issued a Form 483 with 5 observations to BrightGene Fine Chemical Co., Ltd. in Taizhou, Jiangsu (FEI 3011254184). Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
REPEAT OBSERVATION Failure to demonstrate that the manufacturing process can reproducibly manufacture intermediates and active pharmaceutical…
- 02
REPEAT OBSERVATION Failure to establish and follow written procedures for investigating critical deviations or the failure…
- 03
Your firm failed to establish an adequate quality unit that ensures the responsibilities and procedures applicable…
- 04
identity, quality and…
This inspection in context
Questions about this 483
What did FDA find at BrightGene Fine Chemical Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
When was BrightGene Fine Chemical Co., Ltd. inspected by FDA?
This Form 483 is dated January 20, 2024.
How do I get the full Form 483 for BrightGene Fine Chemical 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.