# FDA 483 - Dalton Chemical Laboratories Inc. - December 09, 2022

Source: https://www.keypedia.com/records/483/dalton-chemical-laboratories-inc/c144e593-ea61-4606-868c-701beb8f4518

> FDA 483 for Dalton Chemical Laboratories Inc. on December 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dalton Chemical Laboratories Inc.
- Inspection Date: 2022-12-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Dalton Chemical Laboratories Inc. in North York, a drug manufacturer, was inspected from 12/1/2022 to 12/9/2022. The inspection revealed significant deficiencies in aseptic processing, process controls, out-of-specification investigations, stability testing, laboratory controls, and cleaning validation. These issues indicate a failure to prevent microbiological contamination and assure drug product quality and purity.

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.keypedia.com/companies/dalton-chemical-laboratories-inc/391f58b5-d805-4331-ad7d-cf84533c0736

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