ASO Pharmaceutical Co.,ltd.
Form 483 issued September 8, 2023 · Kikuyomachi, Japan
- Inspection
- Sep 4 – Sep 8, 2023
- Investigator
- Teresa I. Navas
- Observations
- 6
- Pages
- 8
- FEI number
- 1000414460
In short: On September 8, 2023, FDA issued a Form 483 with 6 observations to ASO Pharmaceutical Co.,ltd. in Kikuyomachi, Kumamoto (FEI 1000414460) after an inspection that ran Sep 4 – Sep 8, 2023. The investigator was Teresa I. Navas. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Laboratory controls and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 02
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 03
Deviations from written production and process control procedures are…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Teresa I. Navas
21 documents · 2020–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmASO Pharmaceutical Co.,ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ASO Pharmaceutical Co.,ltd.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected ASO Pharmaceutical Co.,ltd.?
Teresa I. Navas is named on this Form 483, for the inspection of Sep 4 – Sep 8, 2023. Each investigator has a profile showing what they cite most.
When was ASO Pharmaceutical Co.,ltd. inspected by FDA?
The inspection ran Sep 4 – Sep 8, 2023, and the Form 483 is dated September 8, 2023.
How do I get the full Form 483 for ASO Pharmaceutical Co.,ltd.?
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.