FDA Inspection
HRC Laboratories Inc.HRC Laboratories Inc. – FDA Inspection, Jan 23, 2009
Record Details
This FDA Inspection record concerns HRC Laboratories Inc., with an inspection on January 23, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- HRC Laboratories Inc.
- Inspection Date
- January 23, 2009
- Product Type
- Drugs
View Company Profile
ID · 7c36b9f6-64c8-424d-bb70-558788645d8b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 558241
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.182Personnel dating/signing equipment log
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.110(a)Written in-process control procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HRC Laboratories Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 1, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 13, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for HRC Laboratories Inc.
- FDA Inspection 1025426 - 2017-03-03
- FDA Inspection 788988 - 2012-06-01
- FDA Inspection 729195 - 2011-06-13
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.