PharMEDium Services, LLC
Form 483 issued January 5, 2018 · Cleveland, Mississippi
- Inspection
- Nov 27, 2017 – Jan 5, 2018
- Investigators
- Marvin D. Jones· Saundrea A. Munroe
- Observations
- 16
- Pages
- 14
- FEI number
- 3004153061
In short: On January 5, 2018, FDA issued a Form 483 with 16 observations to PharMEDium Services, LLC in Cleveland, Mississippi (FEI 3004153061) after an inspection that ran Nov 27, 2017 – Jan 5, 2018. The investigators were Marvin D. Jones and Saundrea A. Munroe. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Marvin D. Jones
22 documents · 2007–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services, LLC?
FDA listed 16 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 PharMEDium Services, LLC?
Marvin D. Jones and Saundrea A. Munroe are named on this Form 483, for the inspection of Nov 27, 2017 – Jan 5, 2018. Each investigator has a profile showing what they cite most.
When was PharMEDium Services, LLC inspected by FDA?
The inspection ran Nov 27, 2017 – Jan 5, 2018, and the Form 483 is dated January 5, 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.