PharMEDium Services LLC
Form 483 issued December 22, 2017 · Sugar Land, Texas
- Inspection
- Nov 27 – Dec 22, 2017
- Investigators
- Jason R. Caballero· Stephen D. Brown
- Observations
- 13
- Pages
- 10
- FEI number
- 3000717703
In short: On December 22, 2017, FDA issued a Form 483 with 13 observations to PharMEDium Services LLC in Sugar Land, Texas (FEI 3000717703) after an inspection that ran Nov 27 – Dec 22, 2017. The investigators were Jason R. Caballero and Stephen D. Brown. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (4×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to…
- 02
The flow of components, drug product containers, closures, labeling, in-process materials, drug products through the building…
- 03
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological…
- 04
There is a failure to thoroughly investigate any unexplained discrepancy or failure of a batch, regardless…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmPharMEDium Services LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMEDium Services LLC?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected PharMEDium Services LLC?
Jason R. Caballero and Stephen D. Brown are named on this Form 483, for the inspection of Nov 27 – Dec 22, 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 22, 2017, and the Form 483 is dated December 22, 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.