Steri-Pharma, LLC
Form 483 issued October 4, 2022 · Syracuse, New York
- Inspection
- Sep 27 – Oct 4, 2022
- Investigator
- Natasha Gupta
- Observations
- 2
- Pages
- 3
- FEI number
- 3008585015
In short: On October 4, 2022, FDA issued a Form 483 with 2 observations to Steri-Pharma, LLC in Syracuse, New York (FEI 3008585015) after an inspection that ran Sep 27 – Oct 4, 2022. The investigator was Natasha Gupta. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.160(a) (1×) · 211.68(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Established specifications, test procedures and laboratory control mechanisms are not followed and documented at…
- 02
Routine calibration of equipment is not performed according to a written program designed…
This inspection in context
Natasha Gupta
3 documents · 2022
Cites 211.68(a) (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmSteri-Pharma, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Steri-Pharma, LLC?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Steri-Pharma, LLC?
Natasha Gupta is named on this Form 483, for the inspection of Sep 27 – Oct 4, 2022. Each investigator has a profile showing what they cite most.
When was Steri-Pharma, LLC inspected by FDA?
The inspection ran Sep 27 – Oct 4, 2022, and the Form 483 is dated October 4, 2022.
How do I get the full Form 483 for Steri-Pharma, LLC?
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.