# FDA 483 - Inopak Ltd - July 20, 2018

Source: https://www.globalkeysolutions.net/records/483/inopak-ltd/b0d423fb-83ed-471d-844f-8b10236f68e6

> FDA 483 for Inopak Ltd on July 20, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inopak Ltd
- Inspection Date: 2018-07-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Inopak Ltd, an OTC drug manufacturer, revealed significant deficiencies across its quality, laboratory, production, and equipment systems. The firm failed to thoroughly investigate microbial contamination in distributed products, lacked proper quality control oversight, and did not have essential written programs for annual product reviews, stability testing, process validation, equipment maintenance, and cleaning validation. Several observations, particularly regarding process validation, were repeat findings from previous inspections, indicating persistent non-compliance.

## Related Documents

- [WARNING_LETTER - 2018-07-20](https://www.globalkeysolutions.net/records/warning_letter/inopak-ltd/8cfd00c6-76c3-455e-afb3-0692eb7345bc)
- [483 - 2023-08-03](https://www.globalkeysolutions.net/records/483/inopak-ltd/0d756d4b-4d77-43cc-b2d6-1311eee6b310)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)
- [Yvesna Blaise](https://www.globalkeysolutions.net/people/yvesna-blaise/4cd6b7c2-78a7-490d-9354-52046bc7344f)

Company: https://www.globalkeysolutions.net/companies/inopak-ltd/0e7c501d-9636-4cc2-b8dc-f2a1cb0c3f44

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