# FDA 483 - Scapa Tapes North America LLC - February 07, 2020

Source: https://www.globalkeysolutions.net/records/483/scapa-tapes-north-america-llc/36ab4c1b-82bb-4524-b5a5-fa42a35f951b

> FDA 483 for Scapa Tapes North America LLC on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scapa Tapes North America LLC
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Scapa Tapes North America LLC, a drug repackager/relabeler in Knoxville, TN, was cited for two observations during an FDA inspection. The firm failed to adequately document significant steps in batch production and control records and lacked written procedures for master production and control records. These issues indicate deficiencies in the firm's quality control and record-keeping practices.

## Related Officers

- [Kara Dobbin](https://www.globalkeysolutions.net/people/kara-dobbin/0b35e025-4389-46df-abcb-30e70693f62b)
- [Dmitry Galperian](https://www.globalkeysolutions.net/people/dmitry-galperian/32540d2e-10bf-4452-a937-d80226472ef1)
- [investigator](https://www.globalkeysolutions.net/people/steven-j-rush/339b831e-88b6-4b1e-b29a-d8d3ff883ca0)

Company: https://www.globalkeysolutions.net/companies/scapa-tapes-north-america-llc/d8b07485-5fc6-4106-9197-4b4ce2b32623

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9