# FDA 483 - Omega & Delta Co., Inc. - May 06, 2022

Source: https://www.globalkeysolutions.net/records/483/omega-delta-co-inc/81c1badc-152a-476a-b1c4-46f37fd1fd0d

> FDA 483 for Omega & Delta Co., Inc. on May 06, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Omega & Delta Co., Inc.
- Inspection Date: 2022-05-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Omega & Delta Co., Inc. revealed multiple significant deficiencies in their drug manufacturing operations. The firm was cited for numerous violations of current Good Manufacturing Practices, including issues with equipment design, quality control, component identity verification, and discrepancy investigations. Additionally, observations noted problems with stability testing, facility maintenance, microbial control procedures, record-keeping, production controls, and employee training.

## Related Documents

- [WARNING_LETTER - 2022-05-06](https://www.globalkeysolutions.net/records/warning_letter/omega-delta-co-inc/b2adcf5e-c27a-4fb3-9c56-1b63cb934fa5)
- [483 - 2023-10-23](https://www.globalkeysolutions.net/records/483/omega-delta-co-inc/52499281-7aa0-48b8-aab2-b74a7c1cae68)

## Related Officers

- [Angelica M. Hernandez](https://www.globalkeysolutions.net/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)
- [investigator](https://www.globalkeysolutions.net/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6