# FDA 483 - DLC Laboratories, Inc - December 12, 2019

Source: https://www.globalkeysolutions.net/records/483/dlc-laboratories-inc/89471304-34ef-4f78-b0be-b6ae8eb14bb4

> FDA 483 for DLC Laboratories, Inc on December 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DLC Laboratories, Inc
- Inspection Date: 2019-12-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: DLC Laboratories, Inc., a drug manufacturer in Paramount, CA, was inspected and cited for multiple significant deficiencies across its production, quality, facilities, laboratory, packaging, and materials systems. Key issues include inadequate batch records, lack of process validation, insufficient investigations into returned products and recalls, and deficient laboratory controls. These observations indicate a systemic failure to adhere to good manufacturing practices, posing a moderate to severe risk to product quality and patient safety.

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## Related Officers

- [Kouros Kangarli](https://www.globalkeysolutions.net/people/kouros-kangarli/f07f1173-ad7c-4b93-94d7-e805d9be1bb1)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

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