# FDA 483 - Innovation Specialties, Inc. - December 08, 2023

Source: https://www.keypedia.com/records/483/innovation-specialties-inc/4991b2a6-ed90-480a-bf1f-5478d75d9532

> FDA 483 for Innovation Specialties, Inc. on December 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Innovation Specialties, Inc.
- Inspection Date: 2023-12-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Innovation Specialties, Inc. in Culver City, CA, an own label distributor, revealed significant deficiencies in its quality control unit. The firm failed to adequately follow responsibilities and procedures, including insufficient GMP training, non-customized SOPs, lack of QCU approval for controlled documents, and inadequate procedures for equipment maintenance and incoming product testing. These issues indicate a failure to ensure drug products meet applicable good manufacturing practices.

## Related Officers

- [Claudia M. Perez-Kasmarski](https://www.keypedia.com/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

Company: https://www.keypedia.com/companies/innovation-specialties-inc/4171e297-7e30-4094-bf04-b64edbd54848

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