Form 483 · FEI 3002808161
Form 483 issued April 15, 2022 · Toluca, Mexico
- Inspection
- Feb 5, 2021 – Apr 15, 2022
- Investigators
- Joel D. Hustedt· Lisa Shin
- Observations
- 6
- Pages
- 4
- FEI number
- 3002808161
In short: On April 15, 2022, FDA issued a Form 483 with 6 observations to an FDA-inspected site in Toluca, Estado de Mexico (FEI 3002808161) after an inspection that ran Feb 5, 2021 – Apr 15, 2022. The investigators were Joel D. Hustedt and Lisa Shin. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 211.192 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Incidents related to computerized systems that could affect the quality of intermediates or APIs or the…
- 02
re, any control unit failed to implement sufficient controls in computerized systems…
- 03
The firm's quality control unit fails to follow written procedures…
- 04
The firm's quality control unit failed to open investigations for incident logbook entries that impacted the…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmSite history
All 3 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 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Joel D. Hustedt and Lisa Shin are named on this Form 483, for the inspection of Feb 5, 2021 – Apr 15, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Feb 5, 2021 – Apr 15, 2022, and the Form 483 is dated April 15, 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.