American Chinese Medicine Association
Form 483 issued January 20, 2022 · Aurora, Illinois
- Inspection
- Nov 9, 2021 – Jan 20, 2022
- Investigator
- Nicholas P. Diorio
- Observations
- 6
- Pages
- 4
- FEI number
- 3014386146
In short: On January 20, 2022, FDA issued a Form 483 with 6 observations to American Chinese Medicine Association in Aurora, Illinois (FEI 3014386146) after an inspection that ran Nov 9, 2021 – Jan 20, 2022. The investigator was Nicholas P. Diorio. Most observations concern laboratory controls and packaging & labeling.
At a glance
Laboratory controls and packaging & labeling account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
There is no written testing program designed to assess the stability…
- 04
Batch production and control records are not prepared for each batch…
This inspection in context
Nicholas P. Diorio
8 documents · 2013–2025
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in Illinois.
The firmAmerican Chinese Medicine Association history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Chinese Medicine Association?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, packaging & labeling and quality system. The opening words of each observation are shown on this page.
Who inspected American Chinese Medicine Association?
Nicholas P. Diorio is named on this Form 483, for the inspection of Nov 9, 2021 – Jan 20, 2022. Each investigator has a profile showing what they cite most.
When was American Chinese Medicine Association inspected by FDA?
The inspection ran Nov 9, 2021 – Jan 20, 2022, and the Form 483 is dated January 20, 2022.
How do I get the full Form 483 for American Chinese Medicine Association?
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.