FDA Inspection
Rezk Medical SupplyRezk Medical Supply – FDA Inspection, Jan 13, 2012
Record Details
This FDA Inspection record concerns Rezk Medical Supply, with an inspection on January 13, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Rezk Medical Supply
- Inspection Date
- January 13, 2012
- Product Type
- Drugs
View Company Profile
ID · b9a9c1e5-f13b-44d9-819e-b9328ebc5243
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 767201
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
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.