Form 483 · FEI 3011248248
Form 483 issued August 30, 2022 · Iskandar Puteri, Johor, Malaysia
- Inspection
- Aug 22 – Aug 30, 2022
- Investigators
- Anjali Shukla· Hamet Toure· Richard Ledwidge
- Observations
- 4
- Pages
- 5
- FEI number
- 3011248248
In short: On August 30, 2022, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Iskandar Puteri, Johor, Malaysia (FEI 3011248248) after an inspection that ran Aug 22 – Aug 30, 2022. The investigators were Anjali Shukla, Hamet Toure, Richard Ledwidge and Sames Camara. Most observations concern production and facilities & equipment.
At a glance
Observations span 3 systems, led by production.
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
There is a lack of assurance that your cleaning procedures, used for non-product-contact process equipment in…
- 03
Your firm's quatity unit's oversight of your GMP manufacturing and…
- 06
Your batch record documentation…
This inspection in context
Anjali Shukla
3 documents · 2017–2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Austria.
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 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Anjali Shukla, Hamet Toure, Richard Ledwidge and Sames Camara are named on this Form 483, for the inspection of Aug 22 – Aug 30, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Aug 22 – Aug 30, 2022, and the Form 483 is dated August 30, 2022.
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.