# FDA 483 - P & L Development, LLC - November 13, 2018

Source: https://www.keypedia.com/records/483/p-l-development-llc/fe8b19d2-d4d3-4020-813d-3dc607afa458

> FDA 483 for P & L Development, LLC on November 13, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: P & L Development, LLC
- Inspection Date: 2018-11-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of R & S Developments, LLC in Westbury, NY, a drug packager/relabeler, revealed significant deficiencies. The firm failed to implement adequate line clearance processes, resulting in numerous complaints of foreign drug product contamination. Additionally, laboratory records for stability data review were found to be deficient, impacting critical product information.

## Related Documents

- [EIR - 2018-11-13](https://www.keypedia.com/records/eir/p-l-development-llc/5c6083f6-9bad-4066-afed-ec87dc3884d1)

## Related Officers

- [investigator](https://www.keypedia.com/people/jose-o-hernandez/960bffbe-1b8e-41bc-b203-aee88d7d8dac)

Company: https://www.keypedia.com/companies/p-l-development-llc/d4e33c4f-f968-49eb-82c9-230f5f29bcd6

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961