Minaris Regenerative Medicine, LLC
Form 483 issued September 25, 2023 · Allendale, New Jersey
- Investigators
- Alan Baer· Christine Harman· Graeme Price
- Observations
- 1
- Pages
- 2
- FEI number
- 3003407523
In short: On September 25, 2023, FDA issued a Form 483 with 1 observation to Minaris Regenerative Medicine, LLC in Allendale, New Jersey (FEI 3003407523). The investigators were Alan Baer, Christine Harman, Graeme Price and Phillip Thai. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There were multiple instances of failure to follow written standard operating procedures (SOP) in production…
This inspection in context
Alan Baer
1 document · 2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New Jersey.
The firmMinaris Regenerative Medicine, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Minaris Regenerative Medicine, LLC?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Minaris Regenerative Medicine, LLC?
Alan Baer, Christine Harman, Graeme Price and Phillip Thai are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Minaris Regenerative Medicine, LLC inspected by FDA?
This Form 483 is dated September 25, 2023.
How do I get the full Form 483 for Minaris Regenerative Medicine, 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.