# FDA 483 - Alick's Home Medical Equipment, Inc. - September 03, 2021

Source: https://www.keypedia.com/records/483/alicks-home-medical-equipment-inc/147ca8d0-42ac-4cb9-a053-06a48b024df4

> FDA 483 for Alick's Home Medical Equipment, Inc. on September 03, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alick's Home Medical Equipment, Inc.
- Inspection Date: 2021-09-03
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Alick's Home Medical Equipment, Inc. in South Bend, IN, a drug manufacturer, was inspected and cited for multiple deficiencies related to its medical oxygen production. The inspection revealed significant issues with batch production records, adherence to written procedures for component receipt, complaint handling, quality control unit responsibilities, and GMP training. These observations indicate a lack of control over critical manufacturing and quality processes.

## Related Officers

- [Constantin Y. Philopoulos](https://www.keypedia.com/people/constantin-y-philopoulos/536d53f5-7699-4b27-8b4b-10280cce9603)

Company: https://www.keypedia.com/companies/alicks-home-medical-equipment-inc/f196dc27-60ea-4d47-bd5d-91c9be2719f3

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0