Chinese Peptide Company
Form 483 issued June 14, 2024 · Hangzhou, China
- Inspection
- Jun 10 – Jun 14, 2024
- Investigator
- Rajiv R. Srivastava
- Observations
- 2
- Pages
- 4
- FEI number
- 3004518843
In short: On June 14, 2024, FDA issued a Form 483 with 2 observations to Chinese Peptide Company in Hangzhou, Zhejiang (FEI 3004518843) after an inspection that ran Jun 10 – Jun 14, 2024. The investigator was Rajiv R. Srivastava. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You have not established the written procedure to ensure that your process can perform effectively and…
- 02
Appropriate qualification of critical equipment and ancillary systems are not completed to assure that the manufacturing…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmChinese Peptide Company history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chinese Peptide Company?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Chinese Peptide Company?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Jun 10 – Jun 14, 2024. Each investigator has a profile showing what they cite most.
When was Chinese Peptide Company inspected by FDA?
The inspection ran Jun 10 – Jun 14, 2024, and the Form 483 is dated June 14, 2024.
How do I get the full Form 483 for Chinese Peptide Company?
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.