FDA Inspection
MEDICAMEN BIOTECH LIMITEDMEDICAMEN BIOTECH LIMITED – FDA Inspection, Apr 26, 2024
Record Details
This FDA Inspection record concerns MEDICAMEN BIOTECH LIMITED, with an inspection on April 26, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · 361d3bdc-6ec1-499d-bde6-ee75b05b64c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237132
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.68(b)Computer control of master formula records
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.