FEI 3002806479

FDA inspection history in Lerma, Mexico, 2022

1
Form 483

Every document, by year

  • Form 483

2022: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2022One Form 483, at Lerma, Mexico.

Cited most

Across all site observations on file

The complete site file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2022-12-09483 Form 483$99

Investigators on these documents

Alan L. Truong (1)Maria E. Estrella (1)

FEI number 3002806479 · most recent document Dec 9, 2022

About FEI 3002806479

How many FDA Form 483s has FEI 3002806479 received?

FDA Intel has 1 Form 483 on file for FEI 3002806479; the most recent is dated Dec 9, 2022.

When was FEI 3002806479 last inspected by FDA?

The most recent FDA inspection document on file for FEI 3002806479 is a Form 483 dated Dec 9, 2022, for the site in Lerma, Mexico.

What did FDA cite at FEI 3002806479?

The regulations cited most in the observations on file for FEI 3002806479 are 21 CFR 211.170(b) (Reserve samples), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.