# FDA 483 - Milbar Laboratories, Inc. - September 27, 2022

Source: https://www.keypedia.com/records/483/milbar-laboratories-inc/50193e76-a810-4008-9cb0-f954ebccde90

> FDA 483 for Milbar Laboratories, Inc. on September 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Milbar Laboratories, Inc.
- Inspection Date: 2022-09-27
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Milbar Laboratories, Inc. in East Haven, CT, a pharmaceutical manufacturer of OTC drug products, was cited with 13 observations during an FDA inspection. The findings indicate significant deficiencies across multiple quality system areas, including a lack of process and cleaning validation, inadequate stability testing and method validation, failures in quality unit responsibilities, and insufficient controls over computer systems. Several observations were repeats from previous inspections, highlighting persistent issues.

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## Related Officers

- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.keypedia.com/companies/milbar-laboratories-inc/f2d60bc9-405c-493a-a422-7a93d38d883b

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94