Kindeva Drug Delivery Limited
Form 483 issued April 15, 2013 · Loughborough, United Kingdom
- Inspection
- Apr 8 – Apr 15, 2013
- Investigator
- Russell J. Glapion
- Observations
- 3
- Pages
- 2
- FEI number
- 3002807586
In short: On April 15, 2013, FDA issued a Form 483 with 3 observations to Kindeva Drug Delivery Limited in Loughborough, Leicestershire (FEI 3002807586) after an inspection that ran Apr 8 – Apr 15, 2013. The investigator was Russell J. Glapion. Most observations concern materials and quality system.
At a glance
Materials and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product containers or closures are reactive and additive so as to alter the safety, identity…
- 02
Individual equipment logs do not show date, product, and lot number…
- 03
The establishment of specifications, standards, and test procedures including any changes thereto, are not reviewed and…
This inspection in context
Russell J. Glapion
18 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
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 211.94
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kindeva Drug Delivery Limited?
FDA listed 3 observations on this Form 483, mostly about materials, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Kindeva Drug Delivery Limited?
Russell J. Glapion is named on this Form 483, for the inspection of Apr 8 – Apr 15, 2013. Each investigator has a profile showing what they cite most.
When was Kindeva Drug Delivery Limited inspected by FDA?
The inspection ran Apr 8 – Apr 15, 2013, and the Form 483 is dated April 15, 2013.
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.