Jiangsu Anbison Pharmaceutical Co., Ltd.
Form 483 issued July 16, 2024 · Taizhou, China
- Inspection
- Jul 8 – Jul 16, 2024
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 3
- Pages
- 2
- FEI number
- 3021121841
In short: On July 16, 2024, FDA issued a Form 483 with 3 observations to Jiangsu Anbison Pharmaceutical Co., Ltd. in Taizhou, Jiangsu (FEI 3021121841) after an inspection that ran Jul 8 – Jul 16, 2024. The investigator was Patty P. Kaewussdangkul. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production 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
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmJiangsu Anbison Pharmaceutical Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jiangsu Anbison Pharmaceutical Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Jiangsu Anbison Pharmaceutical Co., Ltd.?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Jul 8 – Jul 16, 2024. Each investigator has a profile showing what they cite most.
When was Jiangsu Anbison Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jul 8 – Jul 16, 2024, and the Form 483 is dated July 16, 2024.
How do I get the full Form 483 for Jiangsu Anbison Pharmaceutical 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.