AnazaoHealth Corporation
Form 483 issued September 23, 2024
- Inspection
- Sep 9 – Sep 23, 2024
- Observations
- 3
- Pages
- 3
- FEI number
- 3011152407
In short: On September 23, 2024, FDA issued a Form 483 with 3 observations to AnazaoHealth Corporation (FEI 3011152407) after an inspection that ran Sep 9 – Sep 23, 2024. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and materials account for 2 of 3 observations.
Most cited: 21 CFR 211.192 (1×) · 211.94 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at AnazaoHealth Corporation?
FDA listed 3 observations on this Form 483, mostly about quality system, materials and packaging & labeling. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was AnazaoHealth Corporation inspected by FDA?
The inspection ran Sep 9 – Sep 23, 2024, and the Form 483 is dated September 23, 2024.
How do I get the full Form 483 for AnazaoHealth Corporation?
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.