Micro-X Ltd. Unit 14 6 MAB Eastern Promenade
Form 483 issued May 23, 2024 · Tonsley, Australia
- Inspection
- May 20 – May 23, 2024
- Investigator
- Maryam Tabatabaie
- Observations
- 1
- Pages
- 6
- FEI number
- 3012855798
In short: On May 23, 2024, FDA issued a Form 483 with 1 observation to Micro-X Ltd. Unit 14 6 MAB Eastern Promenade in Tonsley, South (FEI 3012855798) after an inspection that ran May 20 – May 23, 2024. The investigator was Maryam Tabatabaie. Most observations concern cAPA; the most-cited regulation is 21 CFR 806.10 (reports of corrections and removals).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 806.10(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A correction or removal, conducted to reduce a risk to health posed by a device, was…
This inspection in context
Maryam Tabatabaie
11 documents · 2016–2024
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Rhode Island.
The firmMicro-X Ltd. Unit 14 6 MAB Eastern Promenade history
The site's inspection history, in date order.
Similar 483sOther sites cited under 806.10(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Micro-X Ltd. Unit 14 6 MAB Eastern Promenade?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 806.10 (reports of corrections and removals). The opening words of each observation are shown on this page.
Who inspected Micro-X Ltd. Unit 14 6 MAB Eastern Promenade?
Maryam Tabatabaie is named on this Form 483, for the inspection of May 20 – May 23, 2024. Each investigator has a profile showing what they cite most.
When was Micro-X Ltd. Unit 14 6 MAB Eastern Promenade inspected by FDA?
The inspection ran May 20 – May 23, 2024, and the Form 483 is dated May 23, 2024.
How do I get the full Form 483 for Micro-X Ltd. Unit 14 6 MAB Eastern Promenade?
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.