Regenerative Processing Plant, LLC
Form 483 issued June 30, 2023 · Palm, Florida
- Inspection
- Jun 20 – Jun 30, 2023
- Investigators
- Ivan E. Reyes· Samantha J. Pinizzotto· Travis S. Bradley
- Observations
- 15
- Pages
- 13
- FEI number
- 3011320041
In short: On June 30, 2023, FDA issued a Form 483 with 15 observations to Regenerative Processing Plant, LLC in Palm, Florida (FEI 3011320041) after an inspection that ran Jun 20 – Jun 30, 2023. The investigators were Ivan E. Reyes, Samantha J. Pinizzotto and Travis S. Bradley. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Results of stability testing are not used in determining appropriate storage…
- 04
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use…
This inspection in context
Ivan E. Reyes
1 document · 2023
Cites 211.42(a) (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmRegenerative Processing Plant, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Regenerative Processing Plant, LLC?
FDA listed 15 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Regenerative Processing Plant, LLC?
Ivan E. Reyes, Samantha J. Pinizzotto and Travis S. Bradley are named on this Form 483, for the inspection of Jun 20 – Jun 30, 2023. Each investigator has a profile showing what they cite most.
When was Regenerative Processing Plant, LLC inspected by FDA?
The inspection ran Jun 20 – Jun 30, 2023, and the Form 483 is dated June 30, 2023.
How do I get the full Form 483 for Regenerative Processing Plant, 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.