Form 483 · FEI 3000538793
Form 483 issued September 23, 2022 · Ramos Arizpe, Mexico
- Investigators
- Eal I. Ee· Lori B. Wikstrom· Suzanne N. Vallez
- Observations
- 6
- Pages
- 5
- FEI number
- 3000538793
In short: On September 23, 2022, FDA issued a Form 483 with 6 observations to an FDA-inspected site in Ramos Arizpe, Mexico (FEI 3000538793). The investigators were Eal I. Ee, Lori B. Wikstrom, Suzanne N. Vallez and Taichun Qin. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and materials account for 5 of 6 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment is not properly cleaned after use to prevent cross-contamination…
- 02
Procedure for control of foreign matter contamination during production of active pharmaceutical ingredient has…
- 03
Process validation is not conducted for scale-down batch…
- 04
Quality Unit does not properly control batch records and review all critical attributes of the product…
This inspection in context
Eal I. Ee
1 document · 2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Mexico.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
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 production, materials and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Eal I. Ee, Lori B. Wikstrom, Suzanne N. Vallez and Taichun Qin are named on this Form 483. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
This Form 483 is dated September 23, 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.