# FDA 483 - Inopak Ltd - August 03, 2023

Source: https://www.globalkeysolutions.net/records/483/inopak-ltd/ab7aec18-099a-4858-9a57-11015b64c8c1

> 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, a drug manufacturer in Ringwood, NJ, revealed significant deficiencies in its quality control unit regarding contract-manufactured OTC drug products. The firm failed to establish and follow written procedures for quality control, including evaluating formulations, reviewing laboratory results, and managing batch records. Additionally, Inopak Ltd did not perform essential testing, such as for benzene content and microbiological contamination, on finished products distributed to the U.S. market.

## 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/1cd0bba6-ed6a-47da-b191-6d963f4ee8b8

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