Safetec of America Inc.
Form 483 issued October 30, 2015 · Buffalo, New York
- Inspection
- Oct 22 – Oct 30, 2015
- Investigators
- Brian J. Ryan· Matthew D. Schnittker· William Leonard
- Observations
- 7
- Pages
- 8
- FEI number
- 1000159898
In short: On October 30, 2015, FDA issued a Form 483 with 7 observations to Safetec of America Inc. in Buffalo, New York (FEI 1000159898) after an inspection that ran Oct 22 – Oct 30, 2015. The investigators were Brian J. Ryan, Matthew D. Schnittker and William Leonard. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Production and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 02
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 04
Procedures describing the warehousing of drug products are…
This inspection in context
Brian J. Ryan
2 documents · 2015
Cites 211.110 (sampling and testing of in-process materials and drug products) 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 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Safetec of America Inc.?
FDA listed 7 observations on this Form 483, mostly about production, laboratory controls and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Safetec of America Inc.?
Brian J. Ryan, Matthew D. Schnittker and William Leonard are named on this Form 483, for the inspection of Oct 22 – Oct 30, 2015. Each investigator has a profile showing what they cite most.
When was Safetec of America Inc. inspected by FDA?
The inspection ran Oct 22 – Oct 30, 2015, and the Form 483 is dated October 30, 2015.
How do I get the full Form 483 for Safetec of America Inc.?
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