# FDA 483 - Pretika Corporation - October 25, 2019

Source: https://www.globalkeysolutions.net/records/483/pretika-corporation/f6c22232-01d9-438e-92fa-b74fedbc5102

> FDA 483 for Pretika Corporation on October 25, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pretika Corporation
- Inspection Date: 2019-10-25
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Pretika Corporation, a repackager/relabeler in Laguna Niguel, CA, received a Form FDA 483 with seven observations during an inspection from October 22-25, 2019. The inspection revealed a significant lack of established procedures across multiple critical quality system areas. This indicates a fundamental absence of a robust quality management system, impacting complaint handling, corrective and preventive actions, medical device reporting, purchasing controls, document control, labeling, and device history records.

## Related Officers

- [Angelica G Aziz](https://www.globalkeysolutions.net/people/angelica-g-aziz/3aea89c9-72d6-4865-984e-936dd61d2786)

Company: https://www.globalkeysolutions.net/companies/pretika-corporation/e6a13877-2cc1-43af-995e-4831da740a3a

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