ACI HealthCare Limited
Form 483 issued April 1, 2022 · Narayanganj, Bangladesh
- Inspection
- Mar 27 – Apr 1, 2022
- Investigator
- Arsen Karapetyan
- Observations
- 3
- Pages
- 4
- FEI number
- 3015523180
In short: On April 1, 2022, FDA issued a Form 483 with 3 observations to ACI HealthCare Limited in Narayanganj, Bangladesh (FEI 3015523180) after an inspection that ran Mar 27 – Apr 1, 2022. The investigator was Arsen Karapetyan. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
EUPLOVEE,S)SGAATURE DATEISSUED The responsibilities and procedures applicable to the quality control unit are not in writing…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ACI HealthCare Limited?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected ACI HealthCare Limited?
Arsen Karapetyan is named on this Form 483, for the inspection of Mar 27 – Apr 1, 2022. Each investigator has a profile showing what they cite most.
When was ACI HealthCare Limited inspected by FDA?
The inspection ran Mar 27 – Apr 1, 2022, and the Form 483 is dated April 1, 2022.
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.