PharMEDium Services LLC
Form 483 issued April 11, 2018 · Lake Forest, Illinois
- Inspection
- Apr 11, 2018
- Investigators
- Bryan L. McGuckin· Michele L. Glendenning
- Observations
- 6
- Pages
- 9
- FEI number
- 3005051736
In short: On April 11, 2018, FDA issued a Form 483 with 6 observations to PharMEDium Services LLC in Lake Forest, Illinois (FEI 3005051736) after an inspection that ran Apr 11, 2018. The investigators were Bryan L. McGuckin and Michele L. Glendenning. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
5 of 6 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Procedures are not established which are designed to assure that the responsible officials of the fnm…
- 02
The responsibilities and procedures applicable to the quality control unit are not fully followed. Electronic records…
- 03
Written records of investigations into unexplained discrepancies do not include…
- 04
Batch production and control records do not include the results of any investigation made into any…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmPharMEDium Services LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.180(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services LLC?
FDA listed 6 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected PharMEDium Services LLC?
Bryan L. McGuckin and Michele L. Glendenning are named on this Form 483, for the inspection of Apr 11, 2018. Each investigator has a profile showing what they cite most.
When was PharMEDium Services LLC inspected by FDA?
The inspection ran Apr 11, 2018, and the Form 483 is dated April 11, 2018.
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.