FDA Inspection
Derma Care Research Labs LLCDerma Care Research Labs LLC – FDA Inspection, Sep 24, 2019
Record Details
This FDA Inspection record concerns Derma Care Research Labs LLC, with an inspection on September 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · e390396a-4011-4b9c-b432-e371f92aee97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102635
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Derma Care Research Labs LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2025 | OAI | Florida District Office | Drug Quality Assurance |
Other documents for Derma Care Research Labs LLC
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.