Ranier's Compounding Laboratory
Form 483 issued February 6, 2019 · Jeannette, Pennsylvania
- Inspection
- May 22, 2018
- Investigator
- Lisa B. Orr
- Observations
- 9
- Pages
- 5
- FEI number
- 3012124170
In short: On February 6, 2019, FDA issued a Form 483 with 9 observations to Ranier's Compounding Laboratory in Jeannette, Pennsylvania (FEI 3012124170) after an inspection that ran May 22, 2018. The investigator was Lisa B. Orr. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 9 of 9 observations.
Most cited: 21 CFR 211.113 (5×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area…
- 02
Personnel engaged in aseptic processing were…
- 03
Equipment was and Materials or supplies were not disinfected prior to entering…
- 04
The use of sporicidal agents in the ISO 5 classified aseptic…
This inspection in context
Lisa B. Orr
9 documents · 2015–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmRanier's Compounding Laboratory history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ranier's Compounding Laboratory?
FDA listed 9 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Ranier's Compounding Laboratory?
Lisa B. Orr is named on this Form 483, for the inspection of May 22, 2018. Each investigator has a profile showing what they cite most.
When was Ranier's Compounding Laboratory inspected by FDA?
The inspection ran May 22, 2018, and the Form 483 is dated February 6, 2019.
How do I get the full Form 483 for Ranier's Compounding Laboratory?
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.