# FDA 483 - Inopak Ltd - June 18, 2021

Source: https://www.keypedia.com/records/483/inopak-ltd/fc0498ec-f1c0-44ad-bbdf-65930436ec2f

> FDA 483 for Inopak Ltd on June 18, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inopak Ltd
- Inspection Date: 2021-06-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Inopak Ltd, an OTC drug manufacturer in Ringwood, NJ, was inspected by the FDA from June 14-18, 2021. The inspection revealed significant deficiencies across multiple areas, including a lack of written procedures for production and process controls, inadequate quality control unit responsibilities, and insufficient laboratory controls. These issues indicate a systemic failure to ensure the identity, strength, quality, and purity of their drug products.

## Related Officers

- [William Leonard](https://www.keypedia.com/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)
- [Attorney](https://www.keypedia.com/people/marcia-d-fields/7dec60da-6a56-4709-b748-c3218da5c116)
- [Investigator ](https://www.keypedia.com/people/juanita-p-versace/dca6c7fb-62ac-4b06-9c77-dbf52fc83422)

Company: https://www.keypedia.com/companies/inopak-ltd/5798f723-6708-4849-9b4b-864a34b98d76

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