Age Management Institute Santa Barbara

Form 483 issued April 12, 2021 · Santa Barbara, California

Inspection
Mar 22 – Apr 12, 2021
Investigator
Taichun Qin
Observations
5
Pages
5
FEI number
3018101540

In short: On April 12, 2021, FDA issued a Form 483 with 5 observations to Age Management Institute Santa Barbara in Santa Barbara, California (FEI 3018101540) after an inspection that ran Mar 22 – Apr 12, 2021. The investigator was Taichun Qin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.56 (sanitation).

At a glance

3 of 5 observations on this 483 concern facilities & equipment.

Facilities & equipment3
Production1
Materials1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    You did not have a HEPA filter over the area to which sterile…

  2. 02

    Non-microbial contamination was observed…

  3. 03

    The aseptic processing areas had difficult to…

  4. 04

    Sporicidal agents ,vere not used 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 Age Management Institute Santa Barbara?

FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.

Who inspected Age Management Institute Santa Barbara?

Taichun Qin is named on this Form 483, for the inspection of Mar 22 – Apr 12, 2021. Each investigator has a profile showing what they cite most.

When was Age Management Institute Santa Barbara inspected by FDA?

The inspection ran Mar 22 – Apr 12, 2021, and the Form 483 is dated April 12, 2021.

How do I get the full Form 483 for Age Management Institute Santa Barbara?

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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