AnuMed International LLC
Form 483 issued November 7, 2023 · Phoenix, Arizona
- Inspection
- Nov 1 – Nov 7, 2023
- Investigator
- Hung H. Do
- Observations
- 6
- Pages
- 11
- FEI number
- 3010164449
In short: On November 7, 2023, FDA issued a Form 483 with 6 observations to AnuMed International LLC in Phoenix, Arizona (FEI 3010164449) after an inspection that ran Nov 1 – Nov 7, 2023. The investigator was Hung H. Do. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls 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
Batch production and control records are not prepared for each batch of drug product produced and…
- 03
An adequate number of batches of each drug product are not tested to determine an appropriate…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Hung H. Do
11 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmAnuMed International LLC 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 AnuMed International LLC?
FDA listed 6 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 AnuMed International LLC?
Hung H. Do is named on this Form 483, for the inspection of Nov 1 – Nov 7, 2023. Each investigator has a profile showing what they cite most.
When was AnuMed International LLC inspected by FDA?
The inspection ran Nov 1 – Nov 7, 2023, and the Form 483 is dated November 7, 2023.
How do I get the full Form 483 for AnuMed International 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.