# FDA 483 - MedisourceRx - October 22, 2020

Source: https://www.keypedia.com/records/483/medisourcerx/ccb3288b-e078-4a5b-9cd1-5526ca70de9d

> FDA 483 for MedisourceRx on October 22, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MedisourceRx
- Inspection Date: 2020-10-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details observations from an inspection, highlighting multiple deficiencies in the facility's quality system and manufacturing processes for drug products, including sterile injectables.

**Observation 1** notes a failure to thoroughly review unexplained discrepancies, specifically major defects from 100% visual inspection. This is a repeat observation. Unknown particles in multiple Glutathione lots and syringes were not identified. An investigation into media fill lots with excessive particulate counts (Deviation-20-002) was deemed inadequate as the conclusion of possible aggregate from media was not confirmed.

**Observation 2** indicates that procedures to prevent microbiological contamination of sterile drug products lack adequate validation of aseptic and sterilization processes. Specifically, not all media fill units from aseptic process simulations (Nov 2019 for syringes, Feb 2020 for vials) were incubated and examined for turbidity.

**Observation 3** states that procedures to prevent microbiological contamination of sterile drug products are not written and followed. During Glutathione batch 64 filling on October 6, 2020, the primary operator's arms rested on the ISO5 LAF hood bench, and a non-wiped scissor was used to open sterile packages.

**Observation 4** identifies that written production and process control procedures are not documented at the time of performance. The actual pump speed used during production was not documented in the batch record, and Glutathione injection fill volume test results were not documented

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## Related Officers

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Company: https://www.keypedia.com/companies/medisourcerx/9a855143-6076-4b52-a4e0-94d0d179a448

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