# FDA 483 - Element Materials Technology Boston - Acton Inc. - January 15, 2019

Source: https://www.globalkeysolutions.net/records/483/element-materials-technology-boston-acton-inc/4203cdbb-e0fc-4fa3-9b12-5f9e7470e84d

> FDA 483 for Element Materials Technology Boston - Acton Inc. on January 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Element Materials Technology Boston - Acton Inc.
- Inspection Date: 2019-01-15
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Microbiology Research Associates, Inc., a control testing laboratory in Acton, MA, was cited for failing to follow established laboratory control mechanisms. Specifically, the firm did not initiate an out-of-specification investigation or notify a client when a drug sample failed endotoxin testing specifications. This indicates a lapse in quality control procedures for drug product testing.

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Company: https://www.globalkeysolutions.net/companies/element-materials-technology-boston-acton-inc/24258d5a-8309-4e67-90f1-adda6124441c

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7