# FDA 483 - Merck Teknika LLC - November 27, 2024

Source: https://www.keypedia.com/records/483/merck-teknika-llc/1ec62fdc-9941-43db-8fcf-4c1957343437

> FDA 483 for Merck Teknika LLC on November 27, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Teknika LLC
- Inspection Date: 2024-11-27
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: From November 19 to November 27, 2024, the FDA inspected the Merck Teknika LLC biological drug manufacturing facility in Durham, North Carolina. The inspection identified several critical deficiencies in the production of the BCG vaccine, primarily concerning quality oversight and sterile processing. Key issues included significant failures by the quality control unit, such as allowing manufacturing equipment that failed its performance tests to remain in use for over a year without proper review. Additionally, the facility lacked essential airflow visualization studies to prove that manual interventions during the filling process did not compromise sterility. Investigators also observed improper cleanroom behaviors, such as operators reaching over sterile containers and failing to follow contamination prevention protocols. Furthermore, the company released vaccine batches despite unexplained high defect rates and failing test results without conducting thorough investigations or risk assessments. These observations were recorded under the authority of the Federal Food, Drug, and Cosmetic Act. While these findings do not represent a final agency determination, Merck Teknika is required to submit a detailed written response to the FDA. This response must outline corrective actions taken or planned to resolve the identified lapses in quality control and manufacturing safety.

## Related Documents

- [483 - 2020-01-14](https://www.keypedia.com/records/483/merck-teknika-llc/9574d733-73fb-4763-9ae1-bdecf1e3dd7e)
- [EIR - 2022-02-23](https://www.keypedia.com/records/eir/merck-teknika-llc/1ca39777-65ac-4c2b-a232-e9f3009979b1)

## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [FDA_PERSONNEL](https://www.keypedia.com/people/lizaida-perez/686fbdca-bfd7-4a73-990a-d8a97e6b88b7)
- [Brentley S. Pittman](https://www.keypedia.com/people/brentley-s-pittman/d583b2b0-e12f-4b7c-a21b-6a0d75cac255)

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