The Aloe Source
Form 483 issued May 20, 2016 · Plano, Texas
- Inspection
- May 2 – May 20, 2016
- Investigator
- Shawn E. Larson
- Observations
- 13
- Pages
- 12
- FEI number
- 3011756331
In short: On May 20, 2016, FDA issued a Form 483 with 13 observations to The Aloe Source in Plano, Texas (FEI 3011756331) after an inspection that ran May 2 – May 20, 2016. The investigator was Shawn E. Larson. Most observations concern quality system and packaging & labeling.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Written procedures for the receipt, storage and examination of packaging and labeling…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Shawn E. Larson
8 documents · 2015–2020
Cites 211.160(a) (general requirements) more than any other section. Most of their documents are for sites in Texas.
The firmThe Aloe Source history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Aloe Source?
FDA listed 13 observations on this Form 483, mostly about quality system, packaging & labeling and materials. The opening words of each observation are shown on this page.
Who inspected The Aloe Source?
Shawn E. Larson is named on this Form 483, for the inspection of May 2 – May 20, 2016. Each investigator has a profile showing what they cite most.
When was The Aloe Source inspected by FDA?
The inspection ran May 2 – May 20, 2016, and the Form 483 is dated May 20, 2016.
How do I get the full Form 483 for The Aloe Source?
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.