ACI HealthCare Limited
FDA inspection history in Narayanganj, Bangladesh, 2022 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23Two Form 483s, at Narayanganj, Bangladesh.
- 2022The longest 483 on file: 3 observations over 4 pages at Narayanganj, Bangladesh.
Cited most
Across all ACI HealthCare Limited observations on file
- 21 CFR 211.142(b)Warehousing procedures1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete ACI HealthCare Limited file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Narayanganj, Bangladesh
Two Form 483s · 2022 to 2023 · 4 observations
Latest: Form 483, Apr 6, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-06 | 483 Form 483 | Narayanganj, Bangladesh | 1 | $99 |
| 2022-04-01 | 483 Form 483 | Narayanganj, Bangladesh | 3 | $99 |
Investigators on these documents
FEI number 3015523180 · most recent document Apr 6, 2023
About ACI HealthCare Limited
How many FDA Form 483s has ACI HealthCare Limited received?
FDA Intel has 2 Form 483s on file for ACI HealthCare Limited; the most recent is dated Apr 6, 2023.
When was ACI HealthCare Limited last inspected by FDA?
The most recent FDA inspection document on file for ACI HealthCare Limited is a Form 483 dated Apr 6, 2023, for the site in Narayanganj, Bangladesh.
What did FDA cite at ACI HealthCare Limited?
The regulations cited most in the observations on file for ACI HealthCare Limited are 21 CFR 211.142(b) (Warehousing procedures), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.