Naturich Cosmetique Labs
Form 483 issued March 6, 2020 · Garland, Texas
- Inspection
- Mar 2 – Mar 6, 2020
- Investigator
- Shelby N. Marler
- Observations
- 3
- Pages
- 2
- FEI number
- 3008480436
In short: On March 6, 2020, FDA issued a Form 483 with 3 observations to Naturich Cosmetique Labs in Garland, Texas (FEI 3008480436) after an inspection that ran Mar 2 – Mar 6, 2020. The investigator was Shelby N. Marler. Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not made of…
- 02
The batch production and control records are deficient in that they do not include documentation of…
- 03
Control procedures are not established which monitor the output of those manufacturing processes that may be…
This inspection in context
Shelby N. Marler
10 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmNaturich Cosmetique Labs history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Naturich Cosmetique Labs?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected Naturich Cosmetique Labs?
Shelby N. Marler is named on this Form 483, for the inspection of Mar 2 – Mar 6, 2020. Each investigator has a profile showing what they cite most.
When was Naturich Cosmetique Labs inspected by FDA?
The inspection ran Mar 2 – Mar 6, 2020, and the Form 483 is dated March 6, 2020.
How do I get the full Form 483 for Naturich Cosmetique Labs?
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.