Ranier's Compounding Laboratory
Form 483 issued April 22, 2016 · Jeannette, Pennsylvania
- Inspection
- Apr 18 – Apr 22, 2016
- Investigator
- Thomas E. Friel
- Observations
- 7
- Pages
- 6
- FEI number
- 3012124170
In short: On April 22, 2016, FDA issued a Form 483 with 7 observations to Ranier's Compounding Laboratory in Jeannette, Pennsylvania (FEI 3012124170) after an inspection that ran Apr 18 – Apr 22, 2016. The investigator was Thomas E. Friel. 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 5 of 7 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Procedures designed to prevent microbiological contamination of dmg products purporting to be sterile do not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Thomas E. Friel
13 documents · 2013–2017
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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ranier's Compounding Laboratory?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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?
Thomas E. Friel is named on this Form 483, for the inspection of Apr 18 – Apr 22, 2016. Each investigator has a profile showing what they cite most.
When was Ranier's Compounding Laboratory inspected by FDA?
The inspection ran Apr 18 – Apr 22, 2016, and the Form 483 is dated April 22, 2016.
How do I get the full Form 483 for Ranier's Compounding Laboratory?
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