FDA Inspection
Nephron Sterile Compounding Center LLCNephron Sterile Compounding Center LLC – FDA Inspection, Feb 21, 2014
Record Details
This FDA Inspection record concerns Nephron Sterile Compounding Center LLC, with an inspection on February 21, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 21, 2014
- Product Type
- Drugs
View Company Profile
ID · f0fe2c96-56d7-410e-b25d-c1c81cf829ec
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 868313
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
18- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- No label copy submitted with AE report (non-Rx drug)
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 314.80(b)Failure to submit follow-up information to FDA
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
Showing 10 of 18 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nephron Sterile Compounding Center LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 20, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 6, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 14, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 13, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Nephron Sterile Compounding Center LLC
- FDA Inspection 1167490 - 2022-04-20
- FDA Inspection 1109980 - 2019-11-15
- FDA Inspection 984347 - 2016-07-06
- FDA Inspection 938418 - 2015-08-14
- FDA Inspection 905361 - 2014-11-13
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.