Nang Kuang Pharmaceutical Co. Ltd.
Form 483 issued April 2, 2024 · Tainan City, Taiwan
- Inspection
- Mar 25 – Apr 2, 2024
- Investigators
- Amir Alavi· James R. Birkenstamm
- Observations
- 6
- Pages
- 4
- FEI number
- 3004396086
In short: On April 2, 2024, FDA issued a Form 483 with 6 observations to Nang Kuang Pharmaceutical Co. Ltd. in Tainan City, Taiwan (FEI 3004396086) after an inspection that ran Mar 25 – Apr 2, 2024. The investigators were Amir Alavi and James R. Birkenstamm. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug product containers or closures are additive so as to alter the safety, identity, strength, quality…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Amir Alavi
9 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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 211.94(a)
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 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Nang Kuang Pharmaceutical Co. Ltd.?
Amir Alavi and James R. Birkenstamm are named on this Form 483, for the inspection of Mar 25 – Apr 2, 2024. Each investigator has a profile showing what they cite most.
When was Nang Kuang Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran Mar 25 – Apr 2, 2024, and the Form 483 is dated April 2, 2024.
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.