Zhejiang Apeloa Biotechnology Co., Ltd.
Form 483 issued September 7, 2023 · Dongyang, China
- Investigator
- Youkeun Kim
- Observations
- 3
- Pages
- 3
- FEI number
- 3006003033
In short: On September 7, 2023, FDA issued a Form 483 with 3 observations to Zhejiang Apeloa Biotechnology Co., Ltd. in Dongyang, Zhejiang (FEI 3006003033). The investigator was Youkeun Kim. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Unexplained discrepancies are not always…
- 02
Laboratory Out of Specification…
- 03
The water manufacturing system does not have fully meaningful validation and is…
This inspection in context
Youkeun Kim
13 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmZhejiang Apeloa Biotechnology Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Apeloa Biotechnology Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Zhejiang Apeloa Biotechnology Co., Ltd.?
Youkeun Kim is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Zhejiang Apeloa Biotechnology Co., Ltd. inspected by FDA?
This Form 483 is dated September 7, 2023.
How do I get the full Form 483 for Zhejiang Apeloa Biotechnology 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.