# FDA 483 - LE PAPILLON LTD. - June 05, 2025

Source: https://www.globalkeysolutions.net/records/483/le-papillon-ltd/b78fe5a5-7f12-41bf-8af2-39cab632a20f

> FDA 483 for LE PAPILLON LTD. on June 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LE PAPILLON LTD.
- Inspection Date: 2025-06-05
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: LE PAPILLON LTD., a contract packager in South Plainfield, NJ, was cited with three observations during an FDA inspection from May 21 to June 5, 2025. The firm failed to establish adequate production and process controls, including validation studies for OTC drug product filling and equipment cleaning. Additionally, the quality control unit's responsibilities were not fully followed, specifically regarding method verification and validation for both compendial and in-house test methods.

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.globalkeysolutions.net/companies/le-papillon-ltd/9458aec0-27ba-4d80-856b-0888b8ad2d2b

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