FDA Inspection
Sheffield Pharmaceuticals, LLCSheffield Pharmaceuticals, LLC – FDA Inspection, Mar 19, 2015
Record Details
This FDA Inspection record concerns Sheffield Pharmaceuticals, LLC, with an inspection on March 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 19, 2015
- Product Type
- Devices
View Company Profile
ID · f08ba3ef-6568-4fa9-9288-12a98530deb2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 921522
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sheffield Pharmaceuticals, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2025 | Not classified | New England District Office | |
| March 15, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 18, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 13, 2012 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Sheffield Pharmaceuticals, LLC
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.