Zhejiang Bamboo Pharmaceuticals Co.,Ltd
Form 483 issued September 27, 2024 · Shaoxing, China
- Inspection
- Sep 23 – Sep 27, 2024
- Observations
- 2
- Pages
- 4
- FEI number
- 3019684157
In short: On September 27, 2024, FDA issued a Form 483 with 2 observations to Zhejiang Bamboo Pharmaceuticals Co.,Ltd in Shaoxing, Zhejiang (FEI 3019684157) after an inspection that ran Sep 23 – Sep 27, 2024. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations into critical deviations or the failure of a batch of intermediate or API to meet…
- 02
Equipment is not cleaned in a manner to prevent build-up and carry-over of a material or…
This inspection in context
Questions about this 483
What did FDA find at Zhejiang Bamboo Pharmaceuticals Co.,Ltd?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Zhejiang Bamboo Pharmaceuticals Co.,Ltd inspected by FDA?
The inspection ran Sep 23 – Sep 27, 2024, and the Form 483 is dated September 27, 2024.
How do I get the full Form 483 for Zhejiang Bamboo Pharmaceuticals 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.