Nang Kuang Pharmaceutical Co. Ltd.
Form 483 issued June 16, 2022 · Tainan City, Taiwan
- Inspection
- Jun 7 – Jun 16, 2022
- Investigator
- Eryn Bo Chi
- Observations
- 13
- Pages
- 5
- FEI number
- 3004396086
In short: On June 16, 2022, FDA issued a Form 483 with 13 observations to Nang Kuang Pharmaceutical Co. Ltd. in Tainan City, Taiwan (FEI 3004396086) after an inspection that ran Jun 7 – Jun 16, 2022. The investigator was Eryn Bo Chi. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 11 of 13 observations.
Most cited: 21 CFR 211.113 (6×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Deviation investigations are…
- 03
Quality Unit’s oversight of drug product…
- 04
The visual inspection program for drug…
This inspection in context
Eryn Bo Chi
1 document · 2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Taiwan.
The firmNang Kuang 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nang Kuang Pharmaceutical Co. Ltd.?
FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment 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 Nang Kuang Pharmaceutical Co. Ltd.?
Eryn Bo Chi is named on this Form 483, for the inspection of Jun 7 – Jun 16, 2022. Each investigator has a profile showing what they cite most.
When was Nang Kuang Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran Jun 7 – Jun 16, 2022, and the Form 483 is dated June 16, 2022.
How do I get the full Form 483 for Nang Kuang 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.