# FDA 483 - Samjan Group, Inc. - March 03, 2022

Source: https://www.globalkeysolutions.net/records/483/samjan-group-inc/f953529b-6045-4d52-b1bf-5eedc182c494

> FDA 483 for Samjan Group, Inc. on March 03, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samjan Group, Inc.
- Inspection Date: 2022-03-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Sanjan Group Inc., dba PLS Analytical, a contract testing laboratory in East Brunswick, NJ, received a Form FDA 483 for significant deficiencies in its quality control and laboratory operations. The inspection revealed inadequate procedures for investigating Out of Specification (OOS) results and a lack of scientific justification for assigning expiration dates to laboratory chemicals. These issues indicate a failure to ensure the quality and purity of drug products.

## Related Documents

- [483 - 2021-05-28](https://www.globalkeysolutions.net/records/483/samjan-group-inc/6617e9c2-3981-49b7-a6e3-9dd13c27f0c4)

## Related Officers

- [Consumer Safety Officer at FDA U.S. Food and Drug Administration](https://www.globalkeysolutions.net/people/ko-u-min/9bb5f33e-857b-4c6f-a550-fdb439760e30)
- [Ankur C. Patel](https://www.globalkeysolutions.net/people/ankur-c-patel/602c7d14-2c48-4929-a07b-6e4c235d7f13)
- [Investigator](https://www.globalkeysolutions.net/people/janet-a-rajan/95741927-9a4d-422b-bd51-01783d962cbe)

Company: https://www.globalkeysolutions.net/companies/samjan-group-inc/d08c91fd-83d7-46c8-81e7-72296c52f27a

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