GlaxoSmithKline Consumer Healthcare
Form 483 issued July 10, 2015 · Aiken, South Carolina
- Inspection
- Jul 6 – Jul 10, 2015
- Investigators
- Adam R. Cooke· Reba A. Gates· Tamara J. Henderson
- Observations
- 4
- Pages
- 3
- FEI number
- 1046838
In short: On July 10, 2015, FDA issued a Form 483 with 4 observations to GlaxoSmithKline Consumer Healthcare in Aiken, South Carolina (FEI 1046838) after an inspection that ran Jul 6 – Jul 10, 2015. The investigators were Adam R. Cooke, Reba A. Gates and Tamara J. Henderson. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures describing the warehousing of drug…
- 03
Written records of investigation of a drug complaint do…
- 04
Written procedures for sanitation…
This inspection in context
Adam R. Cooke
11 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmGlaxoSmithKline Consumer Healthcare history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GlaxoSmithKline Consumer Healthcare?
FDA listed 4 observations on this Form 483, mostly about quality system, materials and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected GlaxoSmithKline Consumer Healthcare?
Adam R. Cooke, Reba A. Gates and Tamara J. Henderson are named on this Form 483, for the inspection of Jul 6 – Jul 10, 2015. Each investigator has a profile showing what they cite most.
When was GlaxoSmithKline Consumer Healthcare inspected by FDA?
The inspection ran Jul 6 – Jul 10, 2015, and the Form 483 is dated July 10, 2015.
How do I get the full Form 483 for GlaxoSmithKline Consumer Healthcare?
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.