FDA Inspection
Strand Cosmetics EuropeStrand Cosmetics Europe – FDA Inspection, Dec 19, 2014
Record Details
This FDA Inspection record concerns Strand Cosmetics Europe, with an inspection on December 19, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Strand Cosmetics Europe
- Inspection Date
- December 19, 2014
- Product Type
- Drugs
View Company Profile
ID · 10dfbd0e-0114-41da-afe8-8916fd7f7de6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 909723
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.182Written records kept in individual logs
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.