ACI HealthCare Limited
Form 483 issued April 6, 2023 · Narayanganj, Bangladesh
- Inspection
- Apr 2 – Apr 6, 2023
- Investigator
- Gam S. Zamil
- Observations
- 1
- Pages
- 2
- FEI number
- 3015523180
In short: On April 6, 2023, FDA issued a Form 483 with 1 observation to ACI HealthCare Limited in Narayanganj, Bangladesh (FEI 3015523180) after an inspection that ran Apr 2 – Apr 6, 2023. The investigator was Gam S. Zamil. Most observations concern materials; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.142(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmACI HealthCare Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.142(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ACI HealthCare Limited?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected ACI HealthCare Limited?
Gam S. Zamil is named on this Form 483, for the inspection of Apr 2 – Apr 6, 2023. Each investigator has a profile showing what they cite most.
When was ACI HealthCare Limited inspected by FDA?
The inspection ran Apr 2 – Apr 6, 2023, and the Form 483 is dated April 6, 2023.
How do I get the full Form 483 for ACI HealthCare Limited?
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.