FDA Inspection
United States Department of Health & Human ServicesUnited States Department of Health & Human Services – FDA Inspection, Aug 16, 2010
Record Details
This FDA Inspection record concerns United States Department of Health & Human Services, with an inspection on August 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 16, 2010
- Product Type
- Drugs
View Company Profile
ID · 350a7f24-f510-45b8-b79a-72985e13b265
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 675961
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.188(b)(12)Documentation of Batch Investigations
- 21 CFR 211.182Chronological Order of Equipment Log Entries
- 21 CFR 211.182Personnel dating/signing equipment log
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of United States Department of Health & Human Services
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 8, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for United States Department of Health & Human Services
- FDA Inspection 1230131 - 2024-01-18
- FDA Inspection 965269 - 2016-04-08
- FDA Inspection 836346 - 2013-06-18
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.