Orchid Detroit
Form 483 issued March 10, 2016 · Farmington Hills, Michigan
- Inspection
- Feb 29 – Mar 10, 2016
- Investigator
- Sargum C. Sood
- Observations
- 2
- Pages
- 3
- FEI number
- 3011277306
In short: On March 10, 2016, FDA issued a Form 483 with 2 observations to Orchid Detroit in Farmington Hills, Michigan (FEI 3011277306) after an inspection that ran Feb 29 – Mar 10, 2016. The investigator was Sargum C. Sood. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.75 (1×) · 820.90 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures have not been established to control product that does not…
This inspection in context
Sargum C. Sood
5 documents · 2015–2017
Cites 820.30(d) (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmOrchid Detroit history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Orchid Detroit?
FDA listed 2 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Orchid Detroit?
Sargum C. Sood is named on this Form 483, for the inspection of Feb 29 – Mar 10, 2016. Each investigator has a profile showing what they cite most.
When was Orchid Detroit inspected by FDA?
The inspection ran Feb 29 – Mar 10, 2016, and the Form 483 is dated March 10, 2016.
How do I get the full Form 483 for Orchid Detroit?
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.