Form 483 · FEI 3007102377
Form 483 issued December 4, 2018 · Zapopan, Mexico
- Inspection
- Nov 26 – Dec 4, 2018
- Investigator
- Latorie S. Jones
- Observations
- 4
- Pages
- 5
- FEI number
- 3007102377
In short: On December 4, 2018, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Zapopan, Jalisco (FEI 3007102377) after an inspection that ran Nov 26 – Dec 4, 2018. The investigator was Latorie S. Jones. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of a failure of a batch or any of its components to meet any of…
- 02
Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or…
- 03
Your examination and testing of samples did not assure that the drug product and in-process…
- 04
Reserve drug product samples are not representative of each lot or…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
The firmSite history
The site's inspection history, in date order.
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 4 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Latorie S. Jones is named on this Form 483, for the inspection of Nov 26 – Dec 4, 2018. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Nov 26 – Dec 4, 2018, and the Form 483 is dated December 4, 2018.
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.