Company
United StatesSafetec Of America, Inc., Buffalo, NY – FDA Inspections
Inspection records and compliance data for Safetec Of America, Inc. in Buffalo, New York. 8 FDA inspections on record, 2 Form 483s, last inspected November 15, 2024.
Company Profile
This profile covers Safetec Of America, Inc. based in Buffalo, New York, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 8
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected November 25, 2008. Last inspected November 15, 2024.
Most cited issue areas
- Adequate number of batches on stability2 inspections
- Annual visual exams of drug products2 inspections
- Establishment of time limitations2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 15, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1254211 |
| March 6, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1119915 |
| November 17, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1031525 |
| October 30, 2015 | VAI | Human Drugs · Drug Quality Assurance | 947302 |
| August 8, 2012 | VAI | Human Drugs · Drug Quality Assurance | 794760 |
| June 21, 2011 | VAI | Human Drugs · Drug Quality Assurance | 733807 |
| May 27, 2010 | VAI | Human Drugs · Drug Quality Assurance | 669151 |
| November 25, 2008 | VAI | Human Drugs · Drug Quality Assurance | 549816 |
FDA documents
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Company Information
Name
Safetec Of America, Inc.
FEI Number
1000159898
Address
887 Kensington Ave, Buffalo, New York 14215, United States
Country
United States
ID: 1d747a2c-72ac-42e1-8de1-542150a7ffad