# FDA 483 - Novo Nordisk Pharmaceutical Industries LP - July 13, 2023

Source: https://www.keypedia.com/records/483/novo-nordisk-pharmaceutical-industries-lp/07f68227-1226-420a-b605-fb4e3475849f

> FDA 483 for Novo Nordisk Pharmaceutical Industries LP on July 13, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novo Nordisk Pharmaceutical Industries LP
- Inspection Date: 2023-07-13
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Novo Nordisk Pharmaceutical Industries LP, an API Manufacturer located at 3612 Powhatan Rd, Clayton, NC, was conducted from July 6-13, 2023. The inspection identified two observations.

Observation 1 notes a failure to thoroughly investigate the cause of unexplained discrepancies. Specifically, objectionable organisms were identified in intermediate Semaglutide API batches manufactured in the Recovery area on at least three occasions between February and June 2023. Organisms included *Serratia marcescens*, *Acinetobacter guillouiae*, *Enterococcus casseliflavus*, *Enterobacter asburiae*, *Enterobacter bugandensis*, and *Citrobacter freundii*. Deviations DV0134891 and DV0138159, initiated for February and March occurrences, were ineffective in determining the source and corrective actions were inadequate. A new deviation, DV0143695, was initiated for a June 2023 occurrence and is currently open.

Observation 2 indicates deficient microbial controls. Microbial limits have not been established for in-process API material that has had microbes identified during the recovery phase. Additionally, [(b)(4)] used for production is not required to be evaluated for the absence of objectionable organisms unless total microbial counts exceed [(b)(4)].

## Related Documents

- [EIR - 2022-05-13](https://www.keypedia.com/records/eir/novo-nordisk-pharmaceutical-industries-lp/37bcd4d9-2dd4-4e51-9349-32184213bfa8)
- [483 - 2022-05-09](https://www.keypedia.com/records/483/novo-nordisk-pharmaceutical-industries-lp/83be62a1-a352-4d5a-a220-8eb28ceb43b9)
- [483 - 2023-07-06](https://www.keypedia.com/records/483/novo-nordisk-pharmaceutical-industries-lp/281bc5eb-3b36-4b84-8126-0d6364b9f962)
- [EIR - 2023-07-13](https://www.keypedia.com/records/eir/novo-nordisk-pharmaceutical-industries-lp/272bae5d-2bf6-49db-a557-0b48425a5816)

## Related Officers

- [Seneca D. Toms](https://www.keypedia.com/people/seneca-d-toms/3eda62a2-4c12-438f-805a-5e3efb0f2f94)
- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.keypedia.com/companies/novo-nordisk-pharmaceutical-industries-lp/ae9a8861-e1ab-4878-a69f-e2f23284d455

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c