# FDA 483 - Milbar Laboratories, Inc. - November 07, 2024

Source: https://www.globalkeysolutions.net/records/483/milbar-laboratories-inc/85f2abc4-a587-4118-bc19-a92a67fa0bb7

> FDA 483 for Milbar Laboratories, Inc. on November 07, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Milbar Laboratories, Inc.
- Inspection Date: 2024-11-07
- Product Type: drugs
- Office Name: New England District Office
- Summary: Milbar Laboratories, Inc. in East Haven, CT, a manufacturer of OTC drug products, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate stability testing practices, poor facility and equipment maintenance leading to potential contamination, and insufficient quality control oversight. These issues indicate a lack of robust controls to ensure the quality, safety, and purity of their drug products.

## Related Documents

- [483 - 2019-10-11](https://www.globalkeysolutions.net/records/483/milbar-laboratories-inc/5296a9f6-536c-47f3-8d77-b4da51b31485)
- [483 - 2022-09-27](https://www.globalkeysolutions.net/records/483/milbar-laboratories-inc/50193e76-a810-4008-9cb0-f954ebccde90)

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.globalkeysolutions.net/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [Drug Investigator](https://www.globalkeysolutions.net/people/samir-c-gala/904c34ee-013d-4663-a87a-9cbdbcf2b40e)

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

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144