# FDA 483 - Dr. Brite LLC - April 05, 2024

Source: https://www.keypedia.com/records/483/dr-brite-llc/f2ab4fb4-525e-4d30-8bda-416529e6ea4a

> FDA 483 for Dr. Brite LLC on April 05, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Brite LLC
- Inspection Date: 2024-04-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Dr. Brite LLC, a drug manufacturer in Fullerton, CA, was cited for significant deficiencies in its quality control, production, and laboratory systems during an FDA inspection. Observations included a lack of written procedures, inadequate batch records, insufficient component and finished product testing, and no stability program to support expiration dates. These issues indicate a severe lack of adherence to current good manufacturing practices.

## Related Documents

- [WARNING_LETTER - 2024-04-05](https://www.keypedia.com/records/warning_letter/dr-brite-llc/57bcadd9-5fef-4e5f-9821-2237d9705f99)

## Related Officers

- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)

Company: https://www.keypedia.com/companies/dr-brite-llc/a5f0329a-4d30-48bc-90e6-d263937bf8c4

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