Form 483 · FEI 3011248248
Form 483 issued July 20, 2023 · Iskandar Puteri, Malaysia
- Inspection
- Jul 10 – Jul 20, 2023
- Investigators
- Daniel J. Lahar· Eileen A. Liu· Patty P. Kaewussdangkul
- Observations
- 8
- Pages
- 10
- FEI number
- 3011248248
In short: On July 20, 2023, FDA issued a Form 483 with 8 observations to an FDA-inspected site in Iskandar Puteri, Johor (FEI 3011248248) after an inspection that ran Jul 10 – Jul 20, 2023. The investigators were Daniel J. Lahar, Eileen A. Liu, Patty P. Kaewussdangkul and Rong Guo. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Quality system and production account for 5 of 8 observations.
Most cited: 21 CFR 211.113 (2×) · 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 not…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Failure to have written procedures to describe in detail corrective/preventative actions during loss or reversals of…
This inspection in context
Daniel J. Lahar
3 documents · 2007–2025
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmSite history
All 6 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 an FDA-inspected site?
FDA listed 8 observations on this Form 483, mostly about quality system, production and laboratory controls. 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 an FDA-inspected site?
Daniel J. Lahar, Eileen A. Liu, Patty P. Kaewussdangkul and Rong Guo are named on this Form 483, for the inspection of Jul 10 – Jul 20, 2023. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 10 – Jul 20, 2023, and the Form 483 is dated July 20, 2023.
How do I get the full Form 483 for an FDA-inspected site?
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.