Max Chemical, Inc.
Form 483 issued March 15, 2024 · Rio Piedras, Puerto Rico
- Inspection
- Mar 11 – Mar 15, 2024
- Investigators
- Mabany Lizardi· Marian E. Ramirez
- Observations
- 6
- Pages
- 7
- FEI number
- 3002088200
In short: On March 15, 2024, FDA issued a Form 483 with 6 observations to Max Chemical, Inc. in Rio Piedras, Puerto Rico (FEI 3002088200) after an inspection that ran Mar 11 – Mar 15, 2024. The investigators were Mabany Lizardi and Marian E. Ramirez. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Drug product component testing is deficient in that at least one specific test to verify the…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Mabany Lizardi
3 documents · 2024
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in Florida.
The firmMax Chemical, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Max Chemical, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Max Chemical, Inc.?
Mabany Lizardi and Marian E. Ramirez are named on this Form 483, for the inspection of Mar 11 – Mar 15, 2024. Each investigator has a profile showing what they cite most.
When was Max Chemical, Inc. inspected by FDA?
The inspection ran Mar 11 – Mar 15, 2024, and the Form 483 is dated March 15, 2024.
How do I get the full Form 483 for Max Chemical, Inc.?
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.