# FDA 483 - Inopak Ltd - August 03, 2023

Source: https://www.globalkeysolutions.net/records/483/inopak-ltd/0d756d4b-4d77-43cc-b2d6-1311eee6b310

> FDA 483 for Inopak Ltd on August 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inopak Ltd
- Inspection Date: 2023-08-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Inopak Ltd in Ringwood, NJ, a drug manufacturer, revealed significant deficiencies in its quality control unit's responsibilities and procedures. The firm failed to adequately evaluate formulations, review laboratory results, conduct stability studies, and review executed batch records for its OTC drug products. Additionally, Inopak Ltd lacked proper oversight for approving or rejecting contract-manufactured drug products and failed to perform critical testing like benzene content, impurities, and microbiological testing on several distributed products.

## Related Documents

- [483 - 2018-07-20](https://www.globalkeysolutions.net/records/483/inopak-ltd/b0d423fb-83ed-471d-844f-8b10236f68e6)
- [WARNING_LETTER - 2018-07-20](https://www.globalkeysolutions.net/records/warning_letter/inopak-ltd/8cfd00c6-76c3-455e-afb3-0692eb7345bc)

## Related Officers

- [Josh Renzo N. Ramilo](https://www.globalkeysolutions.net/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)
- [Drug Investigator](https://www.globalkeysolutions.net/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

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