# FDA 483 - ACRX Specialty Pharmacy Inc - July 23, 2021

Source: https://www.keypedia.com/records/483/acrx-specialty-pharmacy-inc/ae5708e1-f33e-4046-8aca-7c6cd8ae1fcb

> FDA 483 for ACRX Specialty Pharmacy Inc on July 23, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ACRX Specialty Pharmacy Inc
- Inspection Date: 2021-07-23
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: This FDA Form 483 details observations from an inspection of ACRX Specialty Pharmacy Inc., a producer of sterile and non-sterile drug products, located at 3200 Soaring Gulls Dr Ste 101, Las Vegas, NV 89129-2198. The inspection occurred from July 12, 2021, to July 23, 2021. The report was issued to Eghomware J. Igbinovia, Owner and Pharmacist-in-Charge.

Seven observations were noted:
1.  **ISO 5 Aseptic Processing Area Cleanliness:** The ISO 5 classified aseptic processing areas contained difficult-to-clean and visibly dirty equipment/surfaces, which were not cleaned before and after producing Glutathione (BUD MDV) 200 mg/ml Inject Soln, Lot #07122021@8. Specific issues included brownish stains on the HEPA filter cover and frames, a difficult-to-clean gap in a stainless-steel bar pot rack, and unknown stains under light bulbs.
2.  **Non-Microbial Contamination:** Dusty, filth-like material was present on a non-sterile hood used for non-sterile and sterile product ingredients. Unknown powders were found on the working surface after cleaning, and unknown stains were on the interior of a hood's front window. Rust-

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- [483 - 2019-03-20](https://www.keypedia.com/records/483/acrx-specialty-pharmacy-inc/45dc6f3f-593b-4cec-9994-13c43df3bf97)
- [483 - 2019-03-20](https://www.keypedia.com/records/483/acrx-specialty-pharmacy-inc/74de4671-3ffc-4a41-9f2e-4efc512424a0)
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## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.keypedia.com/companies/acrx-specialty-pharmacy-inc/0ec37ad8-7904-4d10-a13c-652d3c6a458f

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b