Form 483 · FEI 3001119986
Form 483 issued May 25, 2018 · San Jose Iturbide, Mexico
- Inspection
- May 21 – May 25, 2018
- Investigator
- Jessica L. Pressley
- Observations
- 5
- Pages
- 6
- FEI number
- 3001119986
In short: On May 25, 2018, FDA issued a Form 483 with 5 observations to an FDA-inspected site in San Jose Iturbide, Guanajuato (FEI 3001119986) after an inspection that ran May 21 – May 25, 2018. The investigator was Jessica L. Pressley. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 02
Each component is not added to a batch by one person and verified…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Jessica L. Pressley
24 documents · 2014–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 5 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?
Jessica L. Pressley is named on this Form 483, for the inspection of May 21 – May 25, 2018. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran May 21 – May 25, 2018, and the Form 483 is dated May 25, 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.