Form 483 · FEI 3011248248
Form 483 issued September 27, 2024 · Iskander Puteri, Malaysia
- Inspection
- Sep 17 – Sep 27, 2024
- Investigators
- Jeffrey P. Raimondi· Paranthaman Senthamarai Kannan· Sandra A. Boyd
- Observations
- 8
- Pages
- 17
- FEI number
- 3011248248
In short: On September 27, 2024, FDA issued a Form 483 with 8 observations to an FDA-inspected site in Iskander Puteri, Johor (FEI 3011248248) after an inspection that ran Sep 17 – Sep 27, 2024. The investigators were Jeffrey P. Raimondi, Paranthaman Senthamarai Kannan and Sandra A. Boyd. 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 6 of 8 observations.
Most cited: 21 CFR 211.113 (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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
There is a failure to review any unexplained discrepancy whether or not the batch…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 production, facilities & equipment 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?
Jeffrey P. Raimondi, Paranthaman Senthamarai Kannan and Sandra A. Boyd are named on this Form 483, for the inspection of Sep 17 – Sep 27, 2024. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Sep 17 – Sep 27, 2024, and the Form 483 is dated September 27, 2024.
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.