Laboratoires KABS Inc
Form 483 issued January 25, 2024 · Val-des-Sources, Canada
- Inspection
- Jan 22 – Jan 25, 2024
- Investigators
- Maryam Tabatabaie· Wayne D. McGrath
- Observations
- 3
- Pages
- 4
- FEI number
- 3019551074
In short: On January 25, 2024, FDA issued a Form 483 with 3 observations to Laboratoires KABS Inc in Val-des-Sources, Quebec (FEI 3019551074) after an inspection that ran Jan 22 – Jan 25, 2024. The investigators were Maryam Tabatabaie and Wayne D. McGrath. Most observations concern quality system and production & process controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production & process controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Procedures for corrective and preventive action have…
This inspection in context
Maryam Tabatabaie
11 documents · 2016–2024
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Rhode Island.
The firmLaboratoires KABS Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Laboratoires KABS Inc?
FDA listed 3 observations on this Form 483, mostly about quality system, production & process controls and cAPA. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Laboratoires KABS Inc?
Maryam Tabatabaie and Wayne D. McGrath are named on this Form 483, for the inspection of Jan 22 – Jan 25, 2024. Each investigator has a profile showing what they cite most.
When was Laboratoires KABS Inc inspected by FDA?
The inspection ran Jan 22 – Jan 25, 2024, and the Form 483 is dated January 25, 2024.
How do I get the full Form 483 for Laboratoires KABS Inc?
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