# FDA 483 - Porton Biopharma Limited - March 21, 2021

Source: https://www.keypedia.com/records/483/porton-biopharma-limited/39391868-5e9a-47c2-abde-c6a516fecb5c

> FDA 483 for Porton Biopharma Limited on March 21, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Porton Biopharma Limited
- Inspection Date: 2021-03-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Porton Biopharma Limited, a drug substance and sterile drug product manufacturer in Salisbury, United Kingdom, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate customer complaints and out-of-specification results, did not follow procedures to prevent microbiological contamination, and had issues with quality unit responsibilities and documentation of nonconformance events. These observations indicate a serious lack of adherence to good manufacturing practices.

## Related Documents

- [483 - 2021-05-21](https://www.keypedia.com/records/483/porton-biopharma-limited/1aa770d0-bd10-4e73-a218-ee9dc5d90433)

## Related Officers

- [investigator](https://www.keypedia.com/people/tracy-denison/2690d043-2209-4437-999c-634af9ae63cc)
- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.keypedia.com/companies/porton-biopharma-limited/88a6cb10-7c20-4684-bad9-9352fb509563

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1