BotableBook a call
FDA Warning Letter Explorer
Drugs · Nov 5, 2024

Multaler et Cie SAS

4 extracted findings

FDA source excerpt, selected passage

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).
02
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
03
Your firm failed to demonstrate that your chemical and microbiological test methods were appropriate to assure that your product conforms to appropriate standards of identity, strength, quality, and purity. Specifically,
04
Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 211.84(d)(1)21 CFR 211.160(b)21 CFR 211.6321 CFR 201.12821 CFR 210

For background, see Current good manufacturing practice (CGMP). Explore Botable’s work in Pharmaceuticals and Quality and regulatory operations.

Keep exploring

Find related letters →Browse your letters
For regulated teams

Put this kind of reading to
work on your own records.

Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.

Book a call ↗Read the case studies

FDA Warning Letter Alerts

Share this view

Send the same filters, search and view to a colleague.

LinkedIn Email

You choose what to post or send. Sharing a link does not change access to this site.