Chemblend of America LLC
Form 483 issued June 7, 2024 · Bensenville, Illinois
- Inspection
- Jun 7, 2024
- Investigators
- Matthew B. Casale· Tyler Peterson
- Observations
- 5
- Pages
- 3
- FEI number
- 3002992961
In short: On June 7, 2024, FDA issued a Form 483 with 5 observations to Chemblend of America LLC in Bensenville, Illinois (FEI 3002992961) after an inspection that ran Jun 7, 2024. The investigators were Matthew B. Casale and Tyler Peterson. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
3 of 5 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
An adequate number of batches of each drug product are not tested to determine…
- 03
Your examination and testing of samples did not assure that the drug product and in-process…
- 04
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmChemblend of America LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chemblend of America LLC?
FDA listed 5 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Chemblend of America LLC?
Matthew B. Casale and Tyler Peterson are named on this Form 483, for the inspection of Jun 7, 2024. Each investigator has a profile showing what they cite most.
When was Chemblend of America LLC inspected by FDA?
The inspection ran Jun 7, 2024, and the Form 483 is dated June 7, 2024.
How do I get the full Form 483 for Chemblend of America 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.