Avantor Performance Materials LLC
Form 483 issued November 13, 2024 · Paris, Kentucky
- Inspection
- Nov 6 – Nov 13, 2024
- Investigators
- Olumide A. Akinyemi· Paranthaman Senthamaraikannan
- Observations
- 5
- Pages
- 7
- FEI number
- 1045125
In short: On November 13, 2024, FDA issued a Form 483 with 5 observations to Avantor Performance Materials LLC in Paris, Kentucky (FEI 1045125) after an inspection that ran Nov 6 – Nov 13, 2024. The investigators were Olumide A. Akinyemi and Paranthaman Senthamaraikannan. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The persons double-checking the cleaning and maintenance are not signing or initialing the equipment…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Olumide A. Akinyemi
5 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmAvantor Performance Materials LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Avantor Performance Materials LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Avantor Performance Materials LLC?
Olumide A. Akinyemi and Paranthaman Senthamaraikannan are named on this Form 483, for the inspection of Nov 6 – Nov 13, 2024. Each investigator has a profile showing what they cite most.
When was Avantor Performance Materials LLC inspected by FDA?
The inspection ran Nov 6 – Nov 13, 2024, and the Form 483 is dated November 13, 2024.
How do I get the full Form 483 for Avantor Performance Materials LLC?
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.