AUROLAB TRUST DBA Aurolab
Form 483 issued February 6, 2020 · Madurai, India
- Inspection
- Feb 3 – Feb 6, 2020
- Investigator
- Seema S. Singh
- Observations
- 1
- Pages
- 3
- FEI number
- 3002957101
In short: On February 6, 2020, FDA issued a Form 483 with 1 observation to AUROLAB TRUST DBA Aurolab in Madurai, Tamil Nadu (FEI 3002957101) after an inspection that ran Feb 3 – Feb 6, 2020. The investigator was Seema S. Singh. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Seema S. Singh
6 documents · 2015–2020
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmAUROLAB TRUST DBA Aurolab history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AUROLAB TRUST DBA Aurolab?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected AUROLAB TRUST DBA Aurolab?
Seema S. Singh is named on this Form 483, for the inspection of Feb 3 – Feb 6, 2020. Each investigator has a profile showing what they cite most.
When was AUROLAB TRUST DBA Aurolab inspected by FDA?
The inspection ran Feb 3 – Feb 6, 2020, and the Form 483 is dated February 6, 2020.
How do I get the full Form 483 for AUROLAB TRUST DBA Aurolab?
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.