# FDA 483 - Elite Laboratories Inc. - August 01, 2025

Source: https://www.keypedia.com/records/483/elite-laboratories-inc/72ef38ce-446c-421d-8fe3-eaafbf03c945

> FDA 483 for Elite Laboratories Inc. on August 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elite Laboratories Inc.
- Inspection Date: 2025-08-01
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Elite Laboratories Inc. in Northvale, NJ, was inspected from July 21 to August 1, 2025, and received a Form 483 with six observations. The inspection revealed significant deficiencies in laboratory controls, including inadequate OOS investigations and incomplete data records, as well as issues with method validation. Furthermore, the firm lacked adequate written procedures for production and process controls, failed to properly validate manufacturing processes, and had deficiencies in equipment cleaning procedures.

## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)
- [Jenny Sung, Investigator](https://www.keypedia.com/people/jenny-sung-investigator/09d0add0-a454-4775-8a9b-e637d5657523)
- [Lata C. Mathew, Ph.D., Investigator](https://www.keypedia.com/people/lata-c-mathew-phd-investigator/f0682266-2ed3-4fd5-b64d-62944651792c)
- [Jenny Sung](https://www.keypedia.com/people/jenny-sung/f0bfe57e-92b9-4879-9ac3-1e3483b6486a)

Company: https://www.keypedia.com/companies/elite-laboratories-inc/3a35ac94-4900-41aa-8dba-3a91d9ee400d

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248