AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care
Form 483 issued April 25, 2025 · Lafayette, Louisiana
- Investigators
- Jonathan G. Mainsctars· Oorutny P. Kramer
- Observations
- 3
- Pages
- 23
- FEI number
- 2315837
In short: On April 25, 2025, FDA issued a Form 483 with 3 observations to AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care in Lafayette, Louisiana (FEI 2315837). The investigators were Jonathan G. Mainsctars and Oorutny P. Kramer. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate designed to assure that…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Jonathan G. Mainsctars
1 document · 2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Louisiana.
The firmAMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care?
Jonathan G. Mainsctars and Oorutny P. Kramer are named on this Form 483. Each investigator has a profile showing what they cite most.
When was AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care inspected by FDA?
This Form 483 is dated April 25, 2025.
How do I get the full Form 483 for AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care?
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.