# FDA 483 - RECKITT BENCKISER LLC - June 13, 2019

Source: https://www.keypedia.com/records/483/reckitt-benckiser-llc/21d67b93-dd57-4ff1-9845-1fce24c73f3f

> FDA 483 for RECKITT BENCKISER LLC on June 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RECKITT BENCKISER LLC
- Inspection Date: 2019-06-13
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: RECKITT BENCKISER LLC, a repackager in Saint Peters, MO, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm failed to retain reserve samples for drug products and lacked adequate written procedures for handling labeling and packaging materials. Additionally, the quality control unit did not consistently follow its own procedures for deviation investigations, and production procedures were not documented at the time of performance.

## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.keypedia.com/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)

Company: https://www.keypedia.com/companies/reckitt-benckiser-llc/d7704f8b-d7a5-4074-81c1-2e062ff4f4fd

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22