Advanced Therapies, LLC
Form 483 issued April 17, 2015 · Philadelphia, Pennsylvania
- Inspection
- Apr 13 – Apr 17, 2015
- Investigator
- Gayle S. Lawson
- Observations
- 3
- Pages
- 2
- FEI number
- 1000122198
In short: On April 17, 2015, FDA issued a Form 483 with 3 observations to Advanced Therapies, LLC in Philadelphia, Pennsylvania (FEI 1000122198) after an inspection that ran Apr 13 – Apr 17, 2015. The investigator was Gayle S. Lawson. Most observations concern laboratory controls and quality system.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Deviations from written test…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Gayle S. Lawson
10 documents · 2015–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAdvanced Therapies, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Advanced Therapies, LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Advanced Therapies, LLC?
Gayle S. Lawson is named on this Form 483, for the inspection of Apr 13 – Apr 17, 2015. Each investigator has a profile showing what they cite most.
When was Advanced Therapies, LLC inspected by FDA?
The inspection ran Apr 13 – Apr 17, 2015, and the Form 483 is dated April 17, 2015.
How do I get the full Form 483 for Advanced Therapies, LLC?
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.