# FDA 483 - Orly International, Inc. - December 20, 2022

Source: https://www.keypedia.com/records/483/orly-international-inc/39c9e563-689c-49d0-adf0-39074fd0bd1c

> FDA 483 for Orly International, Inc. on December 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orly International, Inc.
- Inspection Date: 2022-12-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Orly International, Inc. in Van Nuys, CA, revealed significant deficiencies in the manufacturing and distribution of its OTC hand sanitizers and antifungal drug products. The firm failed to establish adequate stability data for product expiration dates, lacked a robust stability program, and did not validate its water system or manufacturing equipment. Additionally, issues were noted with cleaning validation, quality control unit responsibilities, and employee cGMP training, indicating a broad lack of adherence to good manufacturing practices.

## Related Officers

- [Crystal Monroy](https://www.keypedia.com/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)
- [Carolina D. Vasquez](https://www.keypedia.com/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)

Company: https://www.keypedia.com/companies/orly-international-inc/0db5a587-8838-48d4-936f-ed5adf811c0e

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