Form 483 · FEI 3004641553
Form 483 issued April 8, 2022 · Naucalpan de Juarez, Mexico
- Inspection
- Apr 4 – Apr 8, 2022
- Investigators
- Joel D. Hustedt· Lisa Shin
- Observations
- 2
- Pages
- 3
- FEI number
- 3004641553
In short: On April 8, 2022, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Naucalpan de Juarez, Mexico (FEI 3004641553) after an inspection that ran Apr 4 – Apr 8, 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 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Records are not kept for…
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
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). 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 Apr 4 – Apr 8, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Apr 4 – Apr 8, 2022, and the Form 483 is dated April 8, 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.