Form 483 · FEI 3003722350
Form 483 issued July 22, 2018 · San Nicolas de los Garza, Mexico
- Inspection
- Jul 17 – Jul 22, 2018
- Investigator
- Kara D. Dobbin
- Observations
- 5
- Pages
- 3
- FEI number
- 3003722350
In short: On July 22, 2018, FDA issued a Form 483 with 5 observations to an FDA-inspected site in San Nicolas de los Garza, Nuevo Leon (FEI 3003722350) after an inspection that ran Jul 17 – Jul 22, 2018. The investigator was Kara D. Dobbin.
What FDA observed
Preview: the opening words of each observation- 01
Lack of Quality Unit oversight…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Failure to conduct process validation on…
- 04
The batch production and control records are deficient in that they are not an accurate reproduction…
This inspection in context
Kara D. Dobbin
5 documents · 2017–2020
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in China.
The firmSite history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 5 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Kara D. Dobbin is named on this Form 483, for the inspection of Jul 17 – Jul 22, 2018. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 17 – Jul 22, 2018, and the Form 483 is dated July 22, 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.