# FDA 483 - ACI HealthCare Limited - April 06, 2023

Source: https://www.keypedia.com/records/483/aci-healthcare-limited/cbaecdc7-a1d3-449b-8108-f945891a054e

> FDA 483 for ACI HealthCare Limited on April 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ACI HealthCare Limited
- Inspection Date: 2023-04-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: ACI HealthCare Limited, a drug product manufacturer in Narayanganj, Bangladesh, was cited for failing to store drug products under appropriate temperature and humidity conditions. The inspection revealed deficiencies in the firm's warehouse temperature mapping studies for both finished drug products and raw materials, as the studies did not represent worst-case summer temperatures. This raises concerns about the identity, strength, quality, and purity of the stored products.

## Related Documents

- [483 - 2022-04-01](https://www.keypedia.com/records/483/aci-healthcare-limited/6ddbac57-90b3-407d-908d-f47bdd1f127d)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

Company: https://www.keypedia.com/companies/aci-healthcare-limited/cf76db93-80cb-41f6-ba36-7ccb31b420f5

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1