Boiron

Form 483 issued November 29, 2024 · Montevrain, France

Observations: 3
Pages: 3
FEI number: 3004351878

In short: On November 29, 2024, FDA issued a Form 483 with 3 observations to Boiron in Montevrain, France (FEI 3004351878). Most observations concern laboratory controls and quality system.

At a glance

Laboratory controls and quality system account for 2 of 3 observations.

Laboratory controls1

Quality system1

Production1

What FDA observed

Preview: the opening words of each observation

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

01
21 CFR 211.165
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
02
21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include…
03
21 CFR 211.113 21 CFR 211.42
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…

The full 483

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

Get the full 483

This inspection in context

The firm

Boiron history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.165

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Boiron?

FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.

When was Boiron inspected by FDA?

This Form 483 is dated November 29, 2024.

How do I get the full Form 483 for Boiron?

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.