Form 483 · FEI 3002806479
Form 483 issued December 9, 2022 · Lerma, Mexico
- Inspection
- Dec 5 – Dec 9, 2022
- Investigators
- Alan L. Truong· Maria E. Estrella
- Observations
- 2
- Pages
- 3
- FEI number
- 3002806479
In short: On December 9, 2022, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Lerma, Mexico (FEI 3002806479) after an inspection that ran Dec 5 – Dec 9, 2022. The investigators were Alan L. Truong and Maria E. Estrella. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.170(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in California.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
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 laboratory controls. 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?
Alan L. Truong and Maria E. Estrella are named on this Form 483, for the inspection of Dec 5 – Dec 9, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Dec 5 – Dec 9, 2022, and the Form 483 is dated December 9, 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.