# FDA 483 - Omega Alpha Pharmaceuticals - February 24, 2022

Source: https://www.keypedia.com/records/483/omega-alpha-pharmaceuticals/f2761755-9dbf-4409-b4e4-2d29f0bec90f

> FDA 483 for Omega Alpha Pharmaceuticals on February 24, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Omega Alpha Pharmaceuticals
- Inspection Date: 2022-02-24
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: Omega Alpha Pharmaceuticals, a dietary supplement manufacturer in Scarborough, was inspected by the FDA and received a Form 483. The inspection revealed significant issues including inadequate pest control, non-compliance with acidified and low-acid canned food regulations, and multiple deficiencies in dietary supplement manufacturing records and quality control testing. These observations indicate potential insanitary conditions and a lack of adherence to regulatory requirements for both food and dietary supplement production.

## Related Officers

- [investigator](https://www.keypedia.com/people/richard-g-fochesato/0d802787-3bc0-43bc-a1dc-90dee648290b)

Company: https://www.keypedia.com/companies/omega-alpha-pharmaceuticals/e17514bd-9c05-428b-b1c5-408106cf5620

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