FDA Inspection
Dermaceutical Laboratories, LLCDermaceutical Laboratories, LLC – FDA Inspection, Mar 1, 2024
Record Details
This FDA Inspection record concerns Dermaceutical Laboratories, LLC, with an inspection on March 1, 2024, issued by the New Jersey District Office, covering human drugs.
View Company Profile
ID · 54c9e423-db21-4e0a-9a52-a5ed2eb709fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1231533
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dermaceutical Laboratories, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 16, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 6, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dermaceutical Laboratories, 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.