FDA Inspection
ACRX Specialty Pharmacy IncACRX Specialty Pharmacy Inc – FDA Inspection, Mar 20, 2019
Record Details
This FDA Inspection record concerns ACRX Specialty Pharmacy Inc, with an inspection on March 20, 2019, issued by the San Francisco District Office, covering human drugs.
- Person
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ID · 5f2edbcf-c3d3-46a2-8d6b-34f2018df9e4
Inspection Facts
- Inspection number
- 1083229
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of ACRX Specialty Pharmacy Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 23, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ACRX Specialty Pharmacy Inc
- FDA Inspection 1148121 - 2021-07-23
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