# FDA 483 - Jamol Laboratories, Inc. - January 12, 2023

Source: https://www.keypedia.com/records/483/jamol-laboratories-inc/363dbd24-32f9-4788-8c09-ede7d55e975f

> FDA 483 for Jamol Laboratories, Inc. on January 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jamol Laboratories, Inc.
- Inspection Date: 2023-01-12
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Jamol Laboratories, Inc. in Emerson, NJ, was inspected regarding its finished drug product manufacturing. The inspection revealed significant deficiencies in process validation, facility maintenance and cleanliness, investigation of product discrepancies, and completeness of batch production records, particularly concerning their Ponaris® OTC drug product. These issues indicate a lack of adequate controls to ensure product quality and consistency.

## Related Documents

- [WARNING_LETTER - 2023-01-12](https://www.keypedia.com/records/warning_letter/jamol-laboratories-inc/96aa2b6a-5f9f-499e-8b2d-32f786ef409b)
- [483 - 2024-12-12](https://www.keypedia.com/records/483/jamol-laboratories-inc/e060af28-3429-4ca1-b662-d6df3ac2972c)

## Related Officers

- [Investigator](https://www.keypedia.com/people/douglas-c-kovacs/2fd80a0c-1314-4eb0-a14b-c98e65bade81)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.keypedia.com/companies/jamol-laboratories-inc/acd4c51c-2154-464d-bbc0-01477a7e4917

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