# FDA 483 - PharOs MT Ltd. - February 06, 2017

Source: https://www.keypedia.com/records/483/pharos-mt-ltd/cce732b7-4813-4853-9edd-46bd837ae850

> FDA 483 for PharOs MT Ltd. on February 06, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PharOs MT Ltd.
- Inspection Date: 2017-02-06
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Arrow Pharm (Malta) Ltd., a human drug manufacturer in Birzebbugia, Malta, was cited for two significant issues during an FDA inspection. The firm's stability program for drug products lacked statistical criteria for test intervals, and a substantial portion of lots were placed in stability well after distribution. Additionally, the validation of manual cleaning procedures for non-dedicated manufacturing equipment was found inadequate, specifically lacking required recovery studies for medium-risk contact surfaces.

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [ROSA MOTTA](https://www.keypedia.com/people/rosa-motta/d4cda714-03c8-4799-850a-427669a1cd69)

Company: https://www.keypedia.com/companies/pharos-mt-ltd/d4645d39-0651-4fd2-bc27-85df3d10535a

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd