FDA Inspection
Proficient Rx LPProficient Rx LP – FDA Inspection, Oct 22, 2015
Record Details
This FDA Inspection record concerns Proficient Rx LP, with an inspection on October 22, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Proficient Rx LP
- Inspection Date
- October 22, 2015
- Product Type
- Drugs
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ID · 4d175a50-9344-4fbc-9717-73ebffaa3e65
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 948193
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Proficient Rx LP
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2026 | Not classified | Los Angeles District Office | |
| December 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 5, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Proficient Rx LP
- FDA Inspection 1326744 - 2026-07-01
- FDA Inspection 1194148 - 2022-12-08
- FDA Inspection 1050816 - 2018-04-05
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