# FDA 483 - Omega & Delta Co., Inc. - March 20, 2026

Source: https://www.keypedia.com/records/483/omega-delta-co-inc/4f8f6255-90aa-426a-baee-5a32f90518d8

> FDA 483 for Omega & Delta Co., Inc. on March 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Omega & Delta Co., Inc.
- Inspection Date: 2026-03-20
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: Omega & Delta Co., Inc., an OTC-Drug Manufacturer in Carolina, PR, received two observations during an FDA inspection. The firm failed to follow its own Standard Operating Procedure for timely annual product reviews and lacked established written procedures for rework and reprocessing of Over-the-Counter products. These findings indicate deficiencies in adhering to and establishing critical quality control procedures.

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## Related Officers

- [Tomika L. Crafter](https://www.keypedia.com/people/tomika-l-crafter/6c8260a0-c026-496d-80f6-9c30877e8f52)

Company: https://www.keypedia.com/companies/omega-delta-co-inc/720ba082-e2a5-4c3a-9c01-b13706d185d0

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8