# FDA 483 - Tower Laboratories Ltd. - May 02, 2019

Source: https://www.keypedia.com/records/483/tower-laboratories-ltd/fea5782e-faa8-47aa-8c48-f8614287fb01

> FDA 483 for Tower Laboratories Ltd. on May 02, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tower Laboratories Ltd.
- Inspection Date: 2019-05-02
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Tower Laboratories Ltd. in Montague, MI, a dietary supplement manufacturer, revealed a significant deficiency in their quality control processes. The firm failed to verify that their laboratory examination and testing methodologies, particularly for ingredient identification using reference standards, were appropriate for their intended use. This indicates a serious lack of scientific rationale and validation for critical quality control procedures.

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## Related Officers

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Company: https://www.keypedia.com/companies/tower-laboratories-ltd/a704e9ff-aed4-475d-b09e-67d4af62c65d

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0