Form 483 · FEI 3002808102
Form 483 issued December 5, 2023 · Lerma, Mexico
- Inspection
- Nov 27 – Dec 5, 2023
- Investigators
- Alan M. Barker· Jose M. Cayuela
- Observations
- 6
- Pages
- 7
- FEI number
- 3002808102
In short: On December 5, 2023, FDA issued a Form 483 with 6 observations to an FDA-inspected site in Lerma, Estado de Mexico (FEI 3002808102) after an inspection that ran Nov 27 – Dec 5, 2023. The investigators were Alan M. Barker and Jose M. Cayuela. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent objectionable microorganisms in drug substance not required to be…
- 03
There is no documentation to support…
- 04
Non-sterile API either intends or claims that it is suitable for use in further processing to…
This inspection in context
Alan M. Barker
10 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
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 laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Alan M. Barker and Jose M. Cayuela are named on this Form 483, for the inspection of Nov 27 – Dec 5, 2023. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Nov 27 – Dec 5, 2023, and the Form 483 is dated December 5, 2023.
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.