GlaxoSmithKline
Form 483 issued January 26, 2018 · Conshohocken, Pennsylvania
- Inspection
- Jan 17 – Jan 26, 2018
- Investigator
- Anita R. Mfoh
- Observations
- 2
- Pages
- 1
- FEI number
- 3004055938
In short: On January 26, 2018, FDA issued a Form 483 with 2 observations to GlaxoSmithKline in Conshohocken, Pennsylvania (FEI 3004055938) after an inspection that ran Jan 17 – Jan 26, 2018. The investigator was Anita R. Mfoh. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (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
The Standard Operational Procedures (SOPs) are incomplete. The responsibilities and procedures applicable to the Quality Control…
- 02
The Hold Time Study for Buffers and Shelf-life Study…
This inspection in context
Anita R. Mfoh
1 document · 2018
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmGlaxoSmithKline history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GlaxoSmithKline?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected GlaxoSmithKline?
Anita R. Mfoh is named on this Form 483, for the inspection of Jan 17 – Jan 26, 2018. Each investigator has a profile showing what they cite most.
When was GlaxoSmithKline inspected by FDA?
The inspection ran Jan 17 – Jan 26, 2018, and the Form 483 is dated January 26, 2018.
How do I get the full Form 483 for GlaxoSmithKline?
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.