FDA Inspection
Safetec Of America, Inc.Safetec Of America, Inc. – FDA Inspection, Oct 30, 2015
Record Details
This FDA Inspection record concerns Safetec Of America, Inc., with an inspection on October 30, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Safetec Of America, Inc.
- Inspection Date
- October 30, 2015
- Product Type
- Drugs
View Company Profile
ID · 088e333c-0a17-455b-8444-844e6b80068a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 947302
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.160(b)(4)Written calibration procedures
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Safetec Of America, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | VAI | New York District Office | Drug Quality Assurance |
| March 6, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 17, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 8, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Safetec Of America, Inc.
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.