FDA Inspection
Weckerle Cosmetics GmbHWeckerle Cosmetics GmbH – FDA Inspection, Aug 15, 2019
Record Details
This FDA Inspection record concerns Weckerle Cosmetics GmbH, with an inspection on August 15, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 1dbc8522-9b94-4494-8874-4b19999fe059
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102432
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
- 21 CFR 211.67(b)Written procedures not established/followed
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.