Zhejiang Peptides Biotech Co., Ltd.
Form 483 issued September 8, 2023 · Shaoxing City, China
- Inspection
- Sep 5 – Sep 8, 2023
- Investigator
- Se Sona Bunrord
- Observations
- 3
- Pages
- 2
- FEI number
- 3015685285
In short: On September 8, 2023, FDA issued a Form 483 with 3 observations to Zhejiang Peptides Biotech Co., Ltd. in Shaoxing City, Zhejiang (FEI 3015685285) after an inspection that ran Sep 5 – Sep 8, 2023. The investigator was Se Sona Bunrord. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm has not established and implemented adequate quality control for highly sensitizing materials The following…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Your firm lacks a scientifically sound cleaning validation program for…
This inspection in context
Se Sona Bunrord
1 document · 2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmZhejiang Peptides Biotech Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Peptides Biotech Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Zhejiang Peptides Biotech Co., Ltd.?
Se Sona Bunrord is named on this Form 483, for the inspection of Sep 5 – Sep 8, 2023. Each investigator has a profile showing what they cite most.
When was Zhejiang Peptides Biotech Co., Ltd. inspected by FDA?
The inspection ran Sep 5 – Sep 8, 2023, and the Form 483 is dated September 8, 2023.
How do I get the full Form 483 for Zhejiang Peptides Biotech 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.