# FDA EIR - Kindeva Drug Delivery Limited - March 05, 2015

Source: https://www.keypedia.com/records/eir/kindeva-drug-delivery-limited/ecaaf407-28e9-4049-8ce6-684d77d4132d

> FDA EIR for Kindeva Drug Delivery Limited on March 05, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Kindeva Drug Delivery Limited
- Inspection Date: 2015-03-05
- Product Type: drugs
- Office Name: Office of Compliance
- Summary: An FDA Good Manufacturing Practice (GMP) inspection of 3M Health Care, Ltd., located at 3M House, Morley Street Loughborough, was conducted from March 2 to March 5, 2015. This inspection, requested by CDER and performed under CP 7356.002 "Drug Manufacturing Inspections," focused on the firm's non-sterile dosage form manufacturing for the US market. The previous inspection in April 2013 had identified three significant issues, resulting in an FDA-483: a failure to implement corrective actions, lack of individual equipment logs, and outdated laboratory methods. These prior commitments were reviewed during the current inspection. The 2015 inspection adopted a systems-based approach, evaluating quality, production, materials, packaging & labeling, and laboratory operations. No formal violations (FDA-483) were issued during this latest visit, though some matters were discussed with management. The FDA recommended classifying this inspection as "No Action Indicated," signifying a satisfactory outcome without requiring specific corrective actions from the company.

## Related Documents

- [483 - 2013-04-15](https://www.keypedia.com/records/483/kindeva-drug-delivery-limited/e2202e78-a597-488c-8aa0-94c6d3e2da9c)
- [483 - 2016-08-12](https://www.keypedia.com/records/483/kindeva-drug-delivery-limited/393c60f6-3623-43c0-ba8c-fefb63f62fff)

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-l-chasey/37971a80-7af1-4658-9a8d-2d65a2b75ec5)
- [issuing_officer](https://www.keypedia.com/people/jeneen-a-huff-robersone/425ab23a-ab3f-4551-8c8a-fd0014184a99)
- [Consumer Safety Officer (Investigator)](https://www.keypedia.com/people/torrance-slayton/4c696f8c-5d66-4465-aca4-e450e76eded9)

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

Office: https://www.keypedia.com/offices/office-of-compliance/d6cb6d9a-dc29-4722-9ba6-783ba341d981