# FDA 483 - Kindeva Drug Delivery Limited - April 15, 2013

Source: https://www.keypedia.com/records/483/kindeva-drug-delivery-limited/e2202e78-a597-488c-8aa0-94c6d3e2da9c

> FDA 483 for Kindeva Drug Delivery Limited on April 15, 2013. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kindeva Drug Delivery Limited
- Inspection Date: 2013-04-15
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of 3M Health Care, Ltd. in Loughborough, United Kingdom, identified significant issues in their pharmaceutical manufacturing processes. Observations included reactive drug product containers leading to product delivery failures, inadequate analytical equipment logbooks lacking essential batch information, and a failure by the Quality Control Unit to formally approve changes to analytical test procedures for over six years. These findings highlight deficiencies in quality control and manufacturing oversight.

## Related Documents

- [EIR - 2015-03-05](https://www.keypedia.com/records/eir/kindeva-drug-delivery-limited/ecaaf407-28e9-4049-8ce6-684d77d4132d)
- [483 - 2016-08-12](https://www.keypedia.com/records/483/kindeva-drug-delivery-limited/393c60f6-3623-43c0-ba8c-fefb63f62fff)

## Related Officers

- [Russell J. Glapion](https://www.keypedia.com/people/russell-j-glapion/54dd6274-563a-44fe-8016-2ebd700be7a0)

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