AnuMed International LLC
FDA inspection history in Phoenix, Arizona, 2023 to 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2023: one Form 483; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24One Form 483 and one warning letter, at Phoenix, Arizona.
Cited most
Across all AnuMed International observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166(b)Stability testing1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete AnuMed International file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Phoenix, Arizona
One warning letter and one Form 483 · 2023 to 2024 · 6 observations
Latest: Warning letter, Aug 20, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-20 | Warning letter Warning letter | Phoenix, Arizona | — | $99 |
| 2023-11-07 | 483 Form 483 | Phoenix, Arizona | 6 | $99 |
Investigators on these documents
FEI number 3010164449 · most recent document Aug 20, 2024
About AnuMed International LLC
How many FDA Form 483s has AnuMed International LLC received?
FDA Intel has 1 Form 483 on file for AnuMed International LLC; the most recent is dated Nov 7, 2023.
When was AnuMed International LLC last inspected by FDA?
The most recent FDA inspection document on file for AnuMed International LLC is a Form 483 dated Nov 7, 2023, for the site in Phoenix, Arizona.
What did FDA cite at AnuMed International LLC?
The regulations cited most in the observations on file for AnuMed International LLC are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.166(b) (Stability testing), 1 time.
Has AnuMed International LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for AnuMed International LLC; the most recent is dated Aug 20, 2024.