# FDA 483 - Syenz Laboratory, LLC - March 05, 2020

Source: https://www.globalkeysolutions.net/records/483/syenz-laboratory-llc/79aaf539-0b90-4a12-bbe0-0ee3680dc8ea

> FDA 483 for Syenz Laboratory, LLC on March 05, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Syenz Laboratory, LLC
- Inspection Date: 2020-03-05
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Syenz Laboratory, LLC, an Own Label Distributor and Control Testing Laboratory in Norwood, NJ, received a Form 483 with eight observations related to significant deficiencies in its quality control, distribution, complaint handling, and laboratory control systems. The firm failed to adequately review batch records, maintain distribution documentation, establish complaint procedures, test components, ensure representative sampling, implement stability testing, conduct microbial testing, and retain reserve samples for its OTC drug products. These issues indicate a lack of robust quality oversight and control over its drug product manufacturing and distribution processes.

## Related Documents

- [483 - 2022-09-30](https://www.globalkeysolutions.net/records/483/syenz-laboratory-llc/bef89831-31dd-4001-917e-bf2c9e708dcb)

## Related Officers

- [Director of Clinical Training](https://www.globalkeysolutions.net/people/helen-verdel/f6caf5a8-74f5-4833-bd00-5579b369f4f9)

Company: https://www.globalkeysolutions.net/companies/syenz-laboratory-llc/22f3d5a9-6815-427e-aaf2-2fa7d897e3bb

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