# FDA 483 - Merck Teknika LLC - January 14, 2020

Source: https://www.keypedia.com/records/483/merck-teknika-llc/9574d733-73fb-4763-9ae1-bdecf1e3dd7e

> FDA 483 for Merck Teknika LLC on January 14, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Teknika LLC
- Inspection Date: 2020-01-14
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: Organon Teknika Corporation LLC in Durham, NC, was inspected and received a Form 483 with ten observations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, cleaning procedures, and adherence to written procedures for sterile drug product manufacturing. Issues also included inadequate statistical procedures, computer system controls, record keeping, component identification, and warehousing practices.

## Related Documents

- [EIR - 2022-02-23](https://www.keypedia.com/records/eir/merck-teknika-llc/1ca39777-65ac-4c2b-a232-e9f3009979b1)
- [483 - 2024-11-27](https://www.keypedia.com/records/483/merck-teknika-llc/1ec62fdc-9941-43db-8fcf-4c1957343437)

## Related Officers

- [Principal Consultant- CMC Biologics, Former FDA regulator with expertise in CMC and GMP for Biologics](https://www.keypedia.com/people/steven-e-bowen/0e32c7e6-285b-4cf1-90e1-8a7a12a38b0c)
- [CSO](https://www.keypedia.com/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)
- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

Company: https://www.keypedia.com/companies/merck-teknika-llc/64024257-325c-45de-a5c2-70cbe8abecf5

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7