FDA Intel

Provepharm Life Solutions

Form 483 issued April 19, 2024 · Marseille, France

Observations
5
Pages
6
FEI number
3017911817

In short: On April 19, 2024, FDA issued a Form 483 with 5 observations to Provepharm Life Solutions in Marseille, France (FEI 3017911817). Most observations concern quality system and facilities & equipment.

At a glance

Quality system and facilities & equipment account for 3 of 5 observations.

Quality system2
Facilities & equipment1
Laboratory controls1
Other1

What FDA observed

Preview: the opening words of each observation

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

  1. 01
    21 CFR 211.192

    Critical deviation and investigations are inadequate and do not include complete data…

  2. 02
    21 CFR 211.22

    Your Quality Unit failed to ensure that production and laboratory control operations…

  3. 03
    21 CFR 211.67

    Validation of equipment cleaning…

  4. 04

    Reserve samples are not…

1 more observation

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

Get the full 483

This inspection in context

The firm

Provepharm Life Solutions history

The site's inspection history, in date order.

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 Provepharm Life Solutions?

FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.

When was Provepharm Life Solutions inspected by FDA?

This Form 483 is dated April 19, 2024.

How do I get the full Form 483 for Provepharm Life Solutions?

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