# FDA 483 - O.L. Products Inc. - August 14, 2019

Source: https://www.globalkeysolutions.net/records/483/ol-products-inc/65dffd8c-af8f-4b02-b2ac-82b9f86e5966

> FDA 483 for O.L. Products Inc. on August 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: O.L. Products Inc.
- Inspection Date: 2019-08-14
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: G.S.L. Products Inc., an OTC repacker in Oldsmar, FL, was cited for significant deficiencies in its quality control unit, cleaning and maintenance procedures, and stability testing program. The inspection revealed a lack of written procedures for critical operations such as purchasing controls, deviation investigations, and change control. Additionally, the firm failed to establish a formal stability program to determine drug product expiry dates.

## Related Officers

- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.globalkeysolutions.net/companies/ol-products-inc/1e340327-c83b-449a-882f-41c3cc54d974

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