# FDA 483 - Impact Fulfillment Services - December 19, 2018

Source: https://www.globalkeysolutions.net/records/483/impact-fulfillment-services/8cdaa07e-5f44-4e1b-9f5c-77ffed12d1df

> FDA 483 for Impact Fulfillment Services on December 19, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Impact Fulfillment Services
- Inspection Date: 2018-12-19
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Impact Fulfillment Services, a drug repacker in Burlington, NC, revealed significant deficiencies across multiple areas. Observations included incomplete batch production records, unsanitary warehouse conditions with spider infestations and inadequate cleaning records, and failure to maintain required record retention for rejected materials. Additionally, the firm did not follow its own customer complaint procedures, failed to identify rejected products in quarantine, and lacked proper quality unit review and approval for equipment calibration.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/lareese-k-thomas/758b3873-995f-4df3-80f6-658c70f23379)
- [Pharmaceutical Specialist/ Investigator ](https://www.globalkeysolutions.net/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)

Company: https://www.globalkeysolutions.net/companies/impact-fulfillment-services/9d54c119-959f-42d9-89e8-265e47674bba

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7