Active Cosmetics Manufacturing Inc

Form 483 issued October 31, 2025 · Orlando, Florida

Inspection
Oct 27 – Oct 31, 2025
Investigator
Pamela N. Agaba
Observations
7
Pages
10
FEI number
3005351079

In short: On October 31, 2025, FDA issued a Form 483 with 7 observations to Active Cosmetics Manufacturing Inc in Orlando, Florida (FEI 3005351079) after an inspection that ran Oct 27 – Oct 31, 2025. The investigator was Pamela N. Agaba. Most observations concern quality system and laboratory controls.

At a glance

Observations span 4 systems, led by quality system.

Quality system2
Laboratory controls2
Production1
Materials1
Other1

What FDA observed

Preview: the opening words of each observation
  1. 01

    There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…

  2. 02

    The written stability testing…

  3. 03

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

  4. 04

    Control procedures are not established which monitor the output and validate the performance of those manufacturing…

3 more observations

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 Active Cosmetics Manufacturing Inc?

FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.

Who inspected Active Cosmetics Manufacturing Inc?

Pamela N. Agaba is named on this Form 483, for the inspection of Oct 27 – Oct 31, 2025. Each investigator has a profile showing what they cite most.

When was Active Cosmetics Manufacturing Inc inspected by FDA?

The inspection ran Oct 27 – Oct 31, 2025, and the Form 483 is dated October 31, 2025.

How do I get the full Form 483 for Active Cosmetics Manufacturing 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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