Drug factory · FDA FEI 3015523180
ACI HealthCare Limited
Sonargaon Museum Gate-1 Road, Treepordi, Sonargaon, Narayanganj, Bangladesh
Problems found, fixed voluntarily at FDA's last inspection, Apr 6, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2023: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gabapentin | Makes it and packages it | Medsource Pharmaceuticals | 45865-216 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 6, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 6, 2023 inspection
- Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
Registered with FDA for: analysis; label; manufacture; pack.