Safetec of America Inc.
Form 483 issued November 15, 2024 · Buffalo, New York
- Inspection
- Nov 12 – Nov 15, 2024
- Investigators
- Raihan A. Chowdhury· Vivin George
- Observations
- 2
- Pages
- 4
- FEI number
- 1000159898
In short: On November 15, 2024, FDA issued a Form 483 with 2 observations to Safetec of America Inc. in Buffalo, New York (FEI 1000159898) after an inspection that ran Nov 12 – Nov 15, 2024. The investigators were Raihan A. Chowdhury and Vivin George. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Raihan A. Chowdhury
4 documents · 2023–2025
Cites 211.188(b)(2) (batch production and control records) more than any other section. Most of their documents are for sites in New York.
The firmSafetec of America Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Safetec of America Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Safetec of America Inc.?
Raihan A. Chowdhury and Vivin George are named on this Form 483, for the inspection of Nov 12 – Nov 15, 2024. Each investigator has a profile showing what they cite most.
When was Safetec of America Inc. inspected by FDA?
The inspection ran Nov 12 – Nov 15, 2024, and the Form 483 is dated November 15, 2024.
How do I get the full Form 483 for Safetec of America Inc.?
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