Form 483 · FEI 1000183111
Form 483 issued December 6, 2019 · Mexico City, Mexico
- Inspection
- Dec 2 – Dec 6, 2019
- Investigator
- Tamil Arasu
- Observations
- 3
- Pages
- 3
- FEI number
- 1000183111
In short: On December 6, 2019, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Mexico City, DF (FEI 1000183111) after an inspection that ran Dec 2 – Dec 6, 2019. The investigator was Tamil Arasu. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
AMV Field Alert Report was not submitted within three working days of receipt of information concerning…
- 03
Stability Studies are not conducted…
This inspection in context
Tamil Arasu
27 documents · 2011–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSite history
All 2 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 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Tamil Arasu is named on this Form 483, for the inspection of Dec 2 – Dec 6, 2019. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Dec 2 – Dec 6, 2019, and the Form 483 is dated December 6, 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.