# FDA 483 - DLC Laboratories, Inc - January 31, 2025

Source: https://www.globalkeysolutions.net/records/483/dlc-laboratories-inc/fe004cd4-204f-4da2-838c-4c54cdee567c

> FDA 483 for DLC Laboratories, Inc on January 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DLC Laboratories, Inc
- Inspection Date: 2025-01-31
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of DLC Laboratories, Inc. in Paramount, CA, a drug manufacturer, revealed a significant deficiency in their quality system. The firm failed to establish written procedures for production and process controls, specifically regarding the evaluation of nitrosamine impurities in amine-containing products. This indicates a moderate severity issue related to drug product quality assurance and control.

## Related Documents

- [483 - 2019-12-12](https://www.globalkeysolutions.net/records/483/dlc-laboratories-inc/89471304-34ef-4f78-b0be-b6ae8eb14bb4)
- [483 - 2025-01-31](https://www.globalkeysolutions.net/records/483/dlc-laboratories-inc/d519706d-4c3a-4828-8ef1-1ca89773ef47)

## Related Officers

- [Statistical Science Director](https://www.globalkeysolutions.net/people/anney-lin/e1dc45a5-a28f-4636-be13-e9bee6f3bc4e)

Company: https://www.globalkeysolutions.net/companies/dlc-laboratories-inc/1c377b00-6f04-4c55-a7a0-aeab13ed8eb3

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6