# FDA 483 - ACRX Specialty Pharmacy Inc - March 20, 2019

Source: https://www.keypedia.com/records/483/acrx-specialty-pharmacy-inc/45dc6f3f-593b-4cec-9994-13c43df3bf97

> FDA 483 for ACRX Specialty Pharmacy Inc on March 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ACRX Specialty Pharmacy Inc
- Inspection Date: 2019-03-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: ACRX Specialty Pharmacy Inc. in Las Vegas, NV, was inspected for its production of sterile and non-sterile drug products. The inspection revealed significant deficiencies across multiple areas, including inadequate procedures for preventing microbiological contamination, insufficient environmental monitoring, and a lack of stability and product testing. These issues indicate a broad lack of control over critical aspects of drug manufacturing and quality assurance.

## Related Documents

- [483 - 2019-03-20](https://www.keypedia.com/records/483/acrx-specialty-pharmacy-inc/74de4671-3ffc-4a41-9f2e-4efc512424a0)
- [483 - 2021-07-23](https://www.keypedia.com/records/483/acrx-specialty-pharmacy-inc/ae5708e1-f33e-4046-8aca-7c6cd8ae1fcb)
- [STATE_REFERRAL_LETTER - 2021-07-12](https://www.keypedia.com/records/state_referral_letter/acrx-specialty-pharmacy-inc/2dbdd88b-ddea-414d-a597-b8f3a38fff51)

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b