FDA Inspection
Unico Research Laboratory Inc. dba Spencer Lab. Int'l.Unico Research Laboratory Inc. dba Spencer Lab. Int'l. – FDA Inspection, May 2, 2013
Record Details
This FDA Inspection record concerns Unico Research Laboratory Inc. dba Spencer Lab. Int'l., with an inspection on May 2, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 2, 2013
- Product Type
- Drugs
View Company Profile
ID · ab8189e3-6a08-4629-b365-c5d0faf0a4dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 829780
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Unico Research Laboratory Inc. dba Spencer Lab. Int'l.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Unico Research Laboratory Inc. dba Spencer Lab. Int'l.
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.