Form 483 · FEI 1000183111
Form 483 issued May 20, 2022 · Mexico City, Mexico
- Inspection
- May 9 – May 20, 2022
- Investigators
- Nicole E. Knowlton· Rafeeq Habeeb
- Observations
- 3
- Pages
- 2
- FEI number
- 1000183111
In short: On May 20, 2022, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Mexico City, DF (FEI 1000183111) after an inspection that ran May 9 – May 20, 2022. The investigators were Nicole E. Knowlton and Rafeeq Habeeb. Most observations concern facilities & equipment and quality system.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
The ©) @ being permitted for use in the ©) system fails to meet standards…
- 03
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
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 211.63
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 facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Nicole E. Knowlton and Rafeeq Habeeb are named on this Form 483, for the inspection of May 9 – May 20, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran May 9 – May 20, 2022, and the Form 483 is dated May 20, 2022.
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.