Anesis Life, LLC
Form 483 issued January 29, 2026 · Macomb, Michigan
- Inspection
- Jan 26 – Jan 29, 2026
- Investigators
- Gabriel Bermudez-Picart· Nicholas J. Presto· Ramia Brzenjy
- Observations
- 7
- Pages
- 5
- FEI number
- 3025468170
In short: On January 29, 2026, FDA issued a Form 483 with 7 observations to Anesis Life, LLC in Macomb, Michigan (FEI 3025468170) after an inspection that ran Jan 26 – Jan 29, 2026. The investigators were Gabriel Bermudez-Picart, Nicholas J. Presto and Ramia Brzenjy. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Suppliers of raw materials used in the manufacturing of your API product were not evaluated or…
- 02
Failure to adequately ensure that active pharmaceutical ingredient (API) products conform to established…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Process validation for the manufacturing of your homeopathic API product was not conducted prior to the…
This inspection in context
Gabriel Bermudez-Picart
3 documents · 2024–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Illinois.
The firmAnesis Life, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Anesis Life, LLC?
FDA listed 7 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Anesis Life, LLC?
Gabriel Bermudez-Picart, Nicholas J. Presto and Ramia Brzenjy are named on this Form 483, for the inspection of Jan 26 – Jan 29, 2026. Each investigator has a profile showing what they cite most.
When was Anesis Life, LLC inspected by FDA?
The inspection ran Jan 26 – Jan 29, 2026, and the Form 483 is dated January 29, 2026.
How do I get the full Form 483 for Anesis Life, LLC?
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.