# FDA 483 - SKYTRONICS LED, Inc. - January 12, 2026

Source: https://www.keypedia.com/records/483/skytronics-led-inc/4e5dbd95-092e-4a9b-b620-e553f58077d7

> FDA 483 for SKYTRONICS LED, Inc. on January 12, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SKYTRONICS LED, Inc.
- Inspection Date: 2026-01-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Skytronics Led, Inc., an OTC drug manufacturer in Burbank, CA, was inspected and found to have significant deficiencies across its quality system, laboratory controls, and facility operations. The firm lacks a functional Quality Control Unit, fails to adequately test drug products for release and stability, and has critical issues with equipment cleaning, maintenance, and water system management. These observations indicate a severe lack of adherence to Good Manufacturing Practices, posing a high risk to drug product quality and patient safety.

## Related Documents

- [483 - 2026-01-12](https://www.keypedia.com/records/483/skytronics-led-inc/e42b8512-008d-4cd4-90b0-4f8715ed02ad)

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.keypedia.com/companies/skytronics-led-inc/ce5e14d6-de8c-4ad6-9454-d03723fcaa47

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