Cosmaceutical Research Laboratory Inc

Form 483 issued October 12, 2024 · Surrey, Canada

Inspection
Oct 7 – Oct 12, 2024
Investigator
Arsen Karapetyan
Observations
5
Pages
6
FEI number
3003878590

In short: On October 12, 2024, FDA issued a Form 483 with 5 observations to Cosmaceutical Research Laboratory Inc in Surrey, British Columbia (FEI 3003878590) after an inspection that ran Oct 7 – Oct 12, 2024. The investigator was Arsen Karapetyan. Most observations concern quality system and laboratory controls.

At a glance

Quality system and laboratory controls account for 3 of 5 observations.

Quality system2
Laboratory controls1
Facilities & equipment1
Production1

What FDA observed

Preview: the opening words of each observation
  1. 01

    Written records of investigations into unexplained discrepancies and the failure of a batch or any of…

  2. 02

    Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…

  3. 03

    Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…

  4. 04

    The responsibilities and procedures applicable to the quality control unit are not in…

1 more observation

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

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Cosmaceutical Research Laboratory Inc?

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

Who inspected Cosmaceutical Research Laboratory Inc?

Arsen Karapetyan is named on this Form 483, for the inspection of Oct 7 – Oct 12, 2024. Each investigator has a profile showing what they cite most.

When was Cosmaceutical Research Laboratory Inc inspected by FDA?

The inspection ran Oct 7 – Oct 12, 2024, and the Form 483 is dated October 12, 2024.

How do I get the full Form 483 for Cosmaceutical Research Laboratory Inc?

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.

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