Form 483, Feb 15, 2018
Form 483 issued February 15, 2018 · Iskandar Puteri, Malaysia
- Inspection
- Feb 6 – Feb 15, 2018
- Investigators
- Jose E. Melendez· Roger F. Zabinski
- Observations
- 1
- Pages
- 7
In short: On February 15, 2018, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Iskandar Puteri, Malaysia after an inspection that ran Feb 6 – Feb 15, 2018. The investigators were Jose E. Melendez and Roger F. Zabinski. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
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…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSite history
The site's inspection history, in date order.
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 1 observation on this Form 483, mostly about production. 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?
Jose E. Melendez and Roger F. Zabinski are named on this Form 483, for the inspection of Feb 6 – Feb 15, 2018. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Feb 6 – Feb 15, 2018, and the Form 483 is dated February 15, 2018.
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.