Dharma Research, Inc.
Form 483 issued March 18, 2019 · Miami, Florida
- Inspection
- Mar 6 – Mar 18, 2019
- Investigator
- Dianiris C. Ayala
- Observations
- 12
- Pages
- 8
- FEI number
- 3010131268
In short: On March 18, 2019, FDA issued a Form 483 with 12 observations to Dharma Research, Inc. in Miami, Florida (FEI 3010131268) after an inspection that ran Mar 6 – Mar 18, 2019. The investigator was Dianiris C. Ayala. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Production & process controls and capa account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for design control…
- 03
Production processes were not developed, conducted, controlled and monitored to ensure that a device…
- 04
Document control procedures have not been maintained. Your firm failed to ensure that document control procedures…
This inspection in context
Dianiris C. Ayala
8 documents · 2009–2024
Cites 820.100 (corrective and preventive action) 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 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dharma Research, Inc.?
FDA listed 12 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Dharma Research, Inc.?
Dianiris C. Ayala is named on this Form 483, for the inspection of Mar 6 – Mar 18, 2019. Each investigator has a profile showing what they cite most.
When was Dharma Research, Inc. inspected by FDA?
The inspection ran Mar 6 – Mar 18, 2019, and the Form 483 is dated March 18, 2019.
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.