Glaxo Operations UK Ltd.
Form 483 issued September 6, 2019 · Ware, United Kingdom
- Inspection
- Sep 2 – Sep 6, 2019
- Investigator
- Erika V. Butler
- Observations
- 1
- Pages
- 1
- FEI number
- 3003262904
In short: On September 6, 2019, FDA issued a Form 483 with 1 observation to Glaxo Operations UK Ltd. in Ware, Hertfordshire (FEI 3003262904) after an inspection that ran Sep 2 – Sep 6, 2019. The investigator was Erika V. Butler. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmGlaxo Operations UK Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Glaxo Operations UK Ltd.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Glaxo Operations UK Ltd.?
Erika V. Butler is named on this Form 483, for the inspection of Sep 2 – Sep 6, 2019. Each investigator has a profile showing what they cite most.
When was Glaxo Operations UK Ltd. inspected by FDA?
The inspection ran Sep 2 – Sep 6, 2019, and the Form 483 is dated September 6, 2019.
How do I get the full Form 483 for Glaxo Operations UK Ltd.?
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.