# FDA 483 - Accurate RX Pharmacy Consulting LLC - September 19, 2018

Source: https://www.keypedia.com/records/483/accurate-rx-pharmacy-consulting-llc/d8cf8d4d-f9aa-4723-a1fc-8068fcbf0443

> FDA 483 for Accurate RX Pharmacy Consulting LLC on September 19, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Accurate RX Pharmacy Consulting LLC
- Inspection Date: 2018-09-19
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: The FDA Form 483 documents observations from an inspection of a facility producing human sterile drug products with Beyond Use Dates greater than 12 hours. The primary aseptic processing area, an ISO 5 classified (b) (4) , (b) (4) , is located within a non-classified room.

Several critical deficiencies were noted:
1.  **Environmental Control:** The ISO 5 (b) (4) , (b) (4) , is (b) (4) in the open position during cleaning and (b) (4) certification, exposing both ISO 5 chambers (ante & main) to unclassified air. This was observed on 9/11/2018 and 9/13/2018.
2.  **Personnel Gowning:** Technicians do not don sterile gowning garb when performing operations inside the ISO 5 (b) (4) during cleaning and (b) (4) certification. This was observed on 9/11/2018 and 9/13/2018.
3.  **Pressure Differential:** The ISO 5 (b) (4) , (b) (4) , does not consistently maintain a positive pressure differential (>0.02” wc) between the main chamber and the ante chamber during material transfers. On 9/11/2018 and 9/

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## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/accurate-rx-pharmacy-consulting-llc/a22d573d-e6cd-495c-98d5-776db9dc2a66

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03