# FDA 483 - Pace Analytical Life Sciences - October 31, 2016

Source: https://www.globalkeysolutions.net/records/483/pace-analytical-life-sciences/8c349a56-6298-4f46-83b8-dbc71a0d915e

> FDA 483 for Pace Analytical Life Sciences on October 31, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pace Analytical Life Sciences
- Inspection Date: 2016-10-31
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Bio-Concept Laboratories, Inc. in Salem, NH, a control testing laboratory, was cited with three observations during an FDA inspection. The firm failed to adequately requalify HPLC instruments, conduct timely and complete investigations into consumer complaints, and provide requested original documents during the inspection. These issues indicate significant deficiencies in quality control, investigation procedures, and record management.

## Related Officers

- [Robert J. Martin](https://www.globalkeysolutions.net/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.globalkeysolutions.net/companies/pace-analytical-life-sciences/7655da13-95c9-4bd0-ab51-757bdcf43ca2

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