# FDA 483 - Miers Laboratories Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/miers-laboratories-ltd/34ef6e51-7541-4f4e-a6e7-f277f342effe

> FDA 483 for Miers Laboratories Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Miers Laboratories Ltd.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Miers Laboratories Ltd., a drug manufacturer in Wainuiomata, New Zealand, received a Form 483 with six observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality control unit, including failures to follow written procedures, inadequate component testing, and deficient master production records. Several observations were repeats from a previous inspection, indicating persistent issues with quality system compliance.

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## Related Officers

- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

Company: https://www.keypedia.com/companies/miers-laboratories-ltd/47998d06-ba52-4aa4-a5d3-ba734e578db0

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1