# FDA 483 - Olein Recovery Corp - March 18, 2021

Source: https://www.globalkeysolutions.net/records/483/olein-recovery-corp/9de30015-03dd-4923-9d09-f1fa2d27dd3e

> FDA 483 for Olein Recovery Corp on March 18, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Olein Recovery Corp
- Inspection Date: 2021-03-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Olein Recovery Corp, an OTC drug own label distributor in Yabucoa, PR, was cited for significant deficiencies in its quality control unit, GMP training, warehouse storage, and product distribution systems. The firm lacked written procedures for critical operations like complaints and recalls, failed to train employees on GMPs, and stored drug products with non-regulated items. Additionally, the company could not track products by lot number for recall purposes, indicating a fundamental lack of control over drug product quality and safety.

## Related Officers

- [Santos E. Camara](https://www.globalkeysolutions.net/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)

Company: https://www.globalkeysolutions.net/companies/olein-recovery-corp/ff27c53c-1a11-4a92-ad20-642b43bce3fe

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab