Safetec of America Inc.
FDA inspection history in Buffalo, New York, 2015 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2020: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Buffalo, New York.
- 2015The longest 483 on file: 7 observations over 8 pages at Buffalo, New York.
- 2020One Form 483, at Buffalo, New York.
- 2024One Form 483, at Buffalo, New York.
Cited most
Across all Safetec of America observations on file
- 21 CFR 211.160(b)General requirements3
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.111Time limitations on production1
The complete Safetec of America file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Buffalo, New York
Three Form 483s · 2015 to 2024 · 11 observations
Latest: Form 483, Nov 15, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-15 | 483 Form 483 | Buffalo, New York | 2 | $99 |
| 2020-03-06 | 483 Form 483 | Buffalo, New York | 2 | $99 |
| 2015-10-30 | 483 Form 483 | Buffalo, New York | 7 | $99 |
Investigators on these documents
Brian J. Ryan (1)Johnna L. Bleem (1)Matthew D. Schnittker (1)Raihan A. Chowdhury (1)Vivin George (1)William Leonard (1)
FEI number 1000159898 · most recent document Nov 15, 2024
About Safetec of America Inc.
How many FDA Form 483s has Safetec of America Inc. received?
FDA Intel has 3 Form 483s on file for Safetec of America Inc.; the most recent is dated Nov 15, 2024.
When was Safetec of America Inc. last inspected by FDA?
The most recent FDA inspection document on file for Safetec of America Inc. is a Form 483 dated Nov 15, 2024, for the site in Buffalo, New York.
What did FDA cite at Safetec of America Inc.?
The regulations cited most in the observations on file for Safetec of America Inc. are 21 CFR 211.160(b) (General requirements), 3 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 2 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times.