PharMEDium Services LLC
Form 483 issued December 13, 2017 · Dayton, New Jersey
- Inspection
- Nov 27 – Dec 13, 2017
- Investigators
- Adetutu Gidado· Nicholas Violand
- Observations
- 11
- Pages
- 12
- FEI number
- 2242985
In short: On December 13, 2017, FDA issued a Form 483 with 11 observations to PharMEDium Services LLC in Dayton, New Jersey (FEI 2242985) after an inspection that ran Nov 27 – Dec 13, 2017. The investigators were Adetutu Gidado and Nicholas Violand. 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 7 of 11 observations.
Most cited: 21 CFR 211.160 (3×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products failing to meet established…
- 02
There is a failure to thoroughly investigate any unexplained discrepancy or failure of a batch, regardless…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Procedures designed to prevent microbiological contamination of drug products purpotting to be sterile are not fully…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmPharMEDium Services LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services LLC?
FDA listed 11 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected PharMEDium Services LLC?
Adetutu Gidado and Nicholas Violand are named on this Form 483, for the inspection of Nov 27 – Dec 13, 2017. Each investigator has a profile showing what they cite most.
When was PharMEDium Services LLC inspected by FDA?
The inspection ran Nov 27 – Dec 13, 2017, and the Form 483 is dated December 13, 2017.
How do I get the full Form 483 for PharMEDium Services 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.