Dharma Research, Inc.
Form 483 issued September 30, 2022 · Miami, Florida
- Inspection
- Sep 19 – Sep 30, 2022
- Investigator
- Jamirya S. Weatherly
- Observations
- 5
- Pages
- 5
- FEI number
- 3010131268
In short: On September 30, 2022, FDA issued a Form 483 with 5 observations to Dharma Research, Inc. in Miami, Florida (FEI 3010131268) after an inspection that ran Sep 19 – Sep 30, 2022. The investigator was Jamirya S. Weatherly. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Jamirya S. Weatherly
2 documents · 2022
Cites 211.188(b)(1) (batch production and control records) more than any other section. Most of their documents are for sites in Florida.
The firmDharma Research, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dharma Research, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected Dharma Research, Inc.?
Jamirya S. Weatherly is named on this Form 483, for the inspection of Sep 19 – Sep 30, 2022. Each investigator has a profile showing what they cite most.
When was Dharma Research, Inc. inspected by FDA?
The inspection ran Sep 19 – Sep 30, 2022, and the Form 483 is dated September 30, 2022.
How do I get the full Form 483 for Dharma Research, 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.