BotableBook a call
FDA Warning Letter Explorer
Drugs · Mar 17, 2022

Vitae Enim Vitae Scientific Inc.

7 extracted findings

FDA source excerpt, selected passage

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

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 establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
02
You failed to establish a procedure which outlines specific training for personnel responsible for the microbiological examination of media fill vials. You also did not require qualified individuals (e.g., microbiologist) to inspect incubated media fill vials for microbial growth.
03
Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
04
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
05
Your firm failed to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)).
06
You failed to adequately inspect your sterile drug products for visible defects and contamination.
07
Failure to address violations may also cause the FDA to withhold issuance of Export Certificates. The FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

Sections and clauses cited

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

21 CFR 211.113(b)21 CFR 211.42(c)(10)(iv)21 CFR 211.2221 CFR 211.19221 CFR 211.110(a)21 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.