Hangzhou ApexTide Biomedical Technology Co., Ltd.
Form 483 issued November 1, 2024 · Hangzhou, China
- Inspection
- Oct 28 – Nov 1, 2024
- Investigator
- Nibin Varghese
- Observations
- 10
- Pages
- 8
- FEI number
- 3027905876
In short: On November 1, 2024, FDA issued a Form 483 with 10 observations to Hangzhou ApexTide Biomedical Technology Co., Ltd. in Hangzhou, Zhejiang (FEI 3027905876) after an inspection that ran Oct 28 – Nov 1, 2024. The investigator was Nibin Varghese. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to demonstrate that your manufacturing process can reproducibly manufacture an Active Pharmaceutical Ingredient meeting…
- 02
Failure to have the procedures and processes necessary to ensure the API manufactured at your facility…
- 03
Failure of your quality unit to ensure that critical deviations…
- 04
Failure of your quality unit to ensure that materials are appropriately tested, and…
This inspection in context
Nibin Varghese
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmHangzhou ApexTide Biomedical Technology Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hangzhou ApexTide Biomedical Technology Co., Ltd.?
FDA listed 10 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Hangzhou ApexTide Biomedical Technology Co., Ltd.?
Nibin Varghese is named on this Form 483, for the inspection of Oct 28 – Nov 1, 2024. Each investigator has a profile showing what they cite most.
When was Hangzhou ApexTide Biomedical Technology Co., Ltd. inspected by FDA?
The inspection ran Oct 28 – Nov 1, 2024, and the Form 483 is dated November 1, 2024.
How do I get the full Form 483 for Hangzhou ApexTide Biomedical Technology 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.