Tiberius, Inc., dba Custom Scripts Pharmacy

Form 483 issued May 18, 2017 · Wesley Chapel, Florida

Inspection
May 15 – May 18, 2017
Investigator
Joanne E. King
Observations
2
Pages
2
FEI number
3004358166

In short: On May 18, 2017, FDA issued a Form 483 with 2 observations to Tiberius, Inc., dba Custom Scripts Pharmacy in Wesley Chapel, Florida (FEI 3004358166) after an inspection that ran May 15 – May 18, 2017. The investigator was Joanne E. King. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

Observations span 1 system, led by facilities & equipment.

Facilities & equipment1
Other1

Most cited: 21 CFR 211.67 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Non-pharmaceutical grade components are used in the formulation…

  2. 02

    Observation 2: scanned text, readable in the full document.

The full 483

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

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This inspection in context

Questions about this 483

What did FDA find at Tiberius, Inc., dba Custom Scripts Pharmacy?

FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.

Who inspected Tiberius, Inc., dba Custom Scripts Pharmacy?

Joanne E. King is named on this Form 483, for the inspection of May 15 – May 18, 2017. Each investigator has a profile showing what they cite most.

When was Tiberius, Inc., dba Custom Scripts Pharmacy inspected by FDA?

The inspection ran May 15 – May 18, 2017, and the Form 483 is dated May 18, 2017.

How do I get the full Form 483 for Tiberius, Inc., dba Custom Scripts Pharmacy?

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