Form 483 · FEI 3011248248
Form 483 issued July 5, 2019 · Iskander Puteri, Malaysia
- Inspection
- Jun 24 – Jul 5, 2019
- Investigators
- Katherine D. Adams· Linda F. Murphy· Maryam Tabatabaie
- Observations
- 12
- Pages
- 12
- FEI number
- 3011248248
In short: On July 5, 2019, FDA issued a Form 483 with 12 observations to an FDA-inspected site in Iskander Puteri, Johor (FEI 3011248248) after an inspection that ran Jun 24 – Jul 5, 2019. The investigators were Katherine D. Adams, Linda F. Murphy and Maryam Tabatabaie. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 04
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate…
This inspection in context
Katherine D. Adams
2 documents · 2017–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 12 observations on this Form 483, mostly about quality system, laboratory controls and production & process controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Katherine D. Adams, Linda F. Murphy and Maryam Tabatabaie are named on this Form 483, for the inspection of Jun 24 – Jul 5, 2019. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jun 24 – Jul 5, 2019, and the Form 483 is dated July 5, 2019.
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.