# FDA 483 - Kindeva Drug Delivery Limited - August 12, 2016

Source: https://www.keypedia.com/records/483/kindeva-drug-delivery-limited/393c60f6-3623-43c0-ba8c-fefb63f62fff

> FDA 483 for Kindeva Drug Delivery Limited on August 12, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kindeva Drug Delivery Limited
- Inspection Date: 2016-08-12
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of 3M Health Care, Ltd. in Loughborough, UK, revealed significant deficiencies in computer system controls and adherence to established laboratory procedures. The firm failed to maintain complete electronic data, ensure data integrity, and implement proper backup protocols for critical testing equipment. These issues indicate a lack of control over master production and control records, impacting product quality assurance.

## Related Documents

- [483 - 2013-04-15](https://www.keypedia.com/records/483/kindeva-drug-delivery-limited/e2202e78-a597-488c-8aa0-94c6d3e2da9c)
- [EIR - 2015-03-05](https://www.keypedia.com/records/eir/kindeva-drug-delivery-limited/ecaaf407-28e9-4049-8ce6-684d77d4132d)

## Related Officers

- [Development Coordinator](https://www.keypedia.com/people/shawn-e-larson/a3515e47-60a3-48ff-b27c-f79bd03db12b)

Company: https://www.keypedia.com/companies/kindeva-drug-delivery-limited/901e9a7f-5182-43e1-9980-391fca7364b7

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321