# FDA 483 - Innova Cosmetic Solutions LLC - November 06, 2019

Source: https://www.keypedia.com/records/483/innova-cosmetic-solutions-llc/2c200dfe-33e5-476a-8272-897fc2b624ab

> FDA 483 for Innova Cosmetic Solutions LLC on November 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Innova Cosmetic Solutions LLC
- Inspection Date: 2019-11-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Innovia Cosmetic Solutions LLC, an OTC drug manufacturer in Frostproof, FL, was cited for significant deficiencies across multiple systems during an FDA inspection. The firm exhibited inadequate laboratory controls, including a lack of potency and microbial testing, unvalidated test methods, and insufficient stability data for finished drug products. Additionally, the inspection revealed issues with quality control unit authority, absence of batch production records, failure to test incoming components, and use of inappropriately designed equipment.

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.keypedia.com/companies/innova-cosmetic-solutions-llc/0153a571-3f9f-487c-bf91-9a3a45334bed

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6