# FDA 483 - Tower Laboratories Ltd. - November 17, 2021

Source: https://www.globalkeysolutions.net/records/483/tower-laboratories-ltd/78b2a93d-abd4-4d60-95c7-e16874da5ee5

> FDA 483 for Tower Laboratories Ltd. on November 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tower Laboratories Ltd.
- Inspection Date: 2021-11-17
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Tower Laboratories Ltd., a drug manufacturer in Montague, MI, was cited for significant deficiencies across its production, quality control, and laboratory operations. Observations included failures to follow written procedures, inadequate investigations into out-of-specification stability results, and deficient laboratory test methods. These issues indicate a lack of robust controls to ensure product quality and compliance.

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## Related Officers

- [Constantin Y. Philopoulos](https://www.globalkeysolutions.net/people/constantin-y-philopoulos/536d53f5-7699-4b27-8b4b-10280cce9603)

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

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