# FDA 483 - American Distilling Inc. - April 26, 2022

Source: https://www.keypedia.com/records/483/american-distilling-inc/c0f48efb-2730-4ea1-a006-06e6106d796a

> FDA 483 for American Distilling Inc. on April 26, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Distilling Inc.
- Inspection Date: 2022-04-26
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of American Distilling Inc., an OTC drug manufacturer in East Hampton, CT, revealed significant deficiencies across multiple areas. The firm failed to adhere to its written stability testing program and lacked adequate release testing for finished products, including microbiological testing. Additionally, the inspection found that written procedures for equipment cleaning and maintenance were not established or followed, and the quality control unit did not consistently perform timely reviews of facility records.

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/samir-c-gala/904c34ee-013d-4663-a87a-9cbdbcf2b40e)

Company: https://www.keypedia.com/companies/american-distilling-inc/6e6d0aa9-6d92-4f66-8aab-06289ec70292

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94