Safetec of America Inc.
Form 483 issued March 6, 2020 · Buffalo, New York
- Inspection
- Mar 2 – Mar 6, 2020
- Investigator
- Johnna L. Bleem
- Observations
- 2
- Pages
- 2
- FEI number
- 1000159898
In short: On March 6, 2020, FDA issued a Form 483 with 2 observations to Safetec of America Inc. in Buffalo, New York (FEI 1000159898) after an inspection that ran Mar 2 – Mar 6, 2020. The investigator was Johnna L. Bleem. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Johnna L. Bleem
6 documents · 2019–2021
Cites 211.67 (equipment cleaning and maintenance) 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 facilities & equipment. 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.?
Johnna L. Bleem is named on this Form 483, for the inspection of Mar 2 – Mar 6, 2020. Each investigator has a profile showing what they cite most.
When was Safetec of America Inc. inspected by FDA?
The inspection ran Mar 2 – Mar 6, 2020, and the Form 483 is dated March 6, 2020.
How do I get the full Form 483 for Safetec of America Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.