Kohana Pharmacy and Center for Regenerative Medicine Inc.
Form 483 issued April 17, 2019 · San Luis Obispo, California
- Inspection
- Apr 10 – Apr 17, 2019
- Investigator
- Uttaniti Limchumroon
- Observations
- 2
- Pages
- 2
- FEI number
- 3013501947
In short: On April 17, 2019, FDA issued a Form 483 with 2 observations to Kohana Pharmacy and Center for Regenerative Medicine Inc. in San Luis Obispo, California (FEI 3013501947) after an inspection that ran Apr 10 – Apr 17, 2019. The investigator was Uttaniti Limchumroon. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-pharmaceutical grade components are used in the formulation…
- 02
Hazardous drugs were produced without providing adequate cleaning of work surfaces and/or cleaning of…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmKohana Pharmacy and Center for Regenerative Medicine Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kohana Pharmacy and Center for Regenerative Medicine Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Kohana Pharmacy and Center for Regenerative Medicine Inc.?
Uttaniti Limchumroon is named on this Form 483, for the inspection of Apr 10 – Apr 17, 2019. Each investigator has a profile showing what they cite most.
When was Kohana Pharmacy and Center for Regenerative Medicine Inc. inspected by FDA?
The inspection ran Apr 10 – Apr 17, 2019, and the Form 483 is dated April 17, 2019.
How do I get the full Form 483 for Kohana Pharmacy and Center for Regenerative Medicine 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.