FDA Intel

PharMEDium Services, LLC

Form 483 issued December 15, 2017 · Memphis, Tennessee

Inspection
Nov 27 – Dec 15, 2017
Investigators
Jennifer L. Huntington· June P. Page· Neda Hamandi
Observations
13
Pages
19
FEI number
3007045542

In short: On December 15, 2017, FDA issued a Form 483 with 13 observations to PharMEDium Services, LLC in Memphis, Tennessee (FEI 3007045542) after an inspection that ran Nov 27 – Dec 15, 2017. The investigators were Jennifer L. Huntington, June P. Page and Neda Hamandi. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Quality system and facilities & equipment account for 8 of 13 observations.

Quality system5
Facilities & equipment3
Production2
Packaging & labeling1
Other2

Most cited: 21 CFR 211.192 (2×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.22(a)

    The quality control unit lacks authority to review production records to assure that no errors have…

  2. 02
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…

  3. 03
    21 CFR 211.42(a)

    Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…

  4. 04
    21 CFR 211.42(c)(10)(v)

    Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…

9 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Jennifer L. Huntington

31 documents · 2015–2023

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.

The firm

PharMEDium Services, LLC history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

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 quality system, facilities & equipment 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?

Jennifer L. Huntington, June P. Page and Neda Hamandi are named on this Form 483, for the inspection of Nov 27 – Dec 15, 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 15, 2017, and the Form 483 is dated December 15, 2017.

How do I get the full Form 483 for PharMEDium Services, LLC?

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