# FDA 483 - RMLC Industries LLC dba Mr. Lulu LLC - December 09, 2022

Source: https://www.keypedia.com/records/483/rmlc-industries-llc-dba-mr-lulu-llc/a19a4899-f7ab-4e3f-9de9-4c6dae2147cc

> FDA 483 for RMLC Industries LLC dba Mr. Lulu LLC on December 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RMLC Industries LLC dba Mr. Lulu LLC
- Inspection Date: 2022-12-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Mr. Lulu LLC, a manufacturer of OTC drug products like Mr. Lulu Sunscreen Drops in Claremont, CA, was cited with five observations during an FDA inspection. The firm demonstrated severe deficiencies across its quality system, facilities, equipment, and production controls, including the complete absence of a quality control unit, lack of essential testing, and no written procedures or validation for critical manufacturing processes. These issues indicate a fundamental lack of adherence to Good Manufacturing Practices, raising significant concerns about product quality, safety, and purity.

## Related Documents

- [WARNING_LETTER - 2022-12-09](https://www.keypedia.com/records/warning_letter/rmlc-industries-llc-dba-mr-lulu-llc/3c784dbf-0295-4da7-b3be-855b6a827385)

## Related Officers

- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.keypedia.com/companies/rmlc-industries-llc-dba-mr-lulu-llc/58ba9cb0-36f4-4366-9407-33df1e4a2e62

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