Kindeva Drug Delivery Limited
Form 483 issued August 12, 2016 · Loughborough, United Kingdom
- Inspection
- Aug 8 – Aug 12, 2016
- Investigator
- Stawen E. Loreen
- Observations
- 2
- Pages
- 2
- FEI number
- 3002807586
In short: On August 12, 2016, FDA issued a Form 483 with 2 observations to Kindeva Drug Delivery Limited in Loughborough, Leicestershire (FEI 3002807586) after an inspection that ran Aug 8 – Aug 12, 2016. The investigator was Stawen E. Loreen. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Established test procedures are…
This inspection in context
Stawen E. Loreen
1 document · 2016
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in United Kingdom.
The firmKindeva Drug Delivery Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kindeva Drug Delivery Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Kindeva Drug Delivery Limited?
Stawen E. Loreen is named on this Form 483, for the inspection of Aug 8 – Aug 12, 2016. Each investigator has a profile showing what they cite most.
When was Kindeva Drug Delivery Limited inspected by FDA?
The inspection ran Aug 8 – Aug 12, 2016, and the Form 483 is dated August 12, 2016.
How do I get the full Form 483 for Kindeva Drug Delivery Limited?
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.