Making Cosmetics, Inc
Form 483 issued January 15, 2016 · Snoqualmie, Washington
- Inspection
- Dec 8, 2015 – Jan 15, 2016
- Investigator
- Nancy E. Byerly
- Observations
- 13
- Pages
- 6
- FEI number
- 3007162174
In short: On January 15, 2016, FDA issued a Form 483 with 13 observations to Making Cosmetics, Inc in Snoqualmie, Washington (FEI 3007162174) after an inspection that ran Dec 8, 2015 – Jan 15, 2016. The investigator was Nancy E. Byerly. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.22 (2×) · 211.188 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not reviewed and approved by…
- 02
There existed 3 versions of the firm's Batch Record Sheet. There was one version (date unknown)…
- 03
Lack ofQCU review for the firm’s in-house calibration records for their…
- 04
The firm’s facilities and equipment lacked any type of controlled air system such as a Laminar…
This inspection in context
Nancy E. Byerly
7 documents · 2015–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Washington.
The firmMaking Cosmetics, Inc 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 Making Cosmetics, Inc?
FDA listed 13 observations on this Form 483, mostly about quality system, production and facilities & equipment. 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 Making Cosmetics, Inc?
Nancy E. Byerly is named on this Form 483, for the inspection of Dec 8, 2015 – Jan 15, 2016. Each investigator has a profile showing what they cite most.
When was Making Cosmetics, Inc inspected by FDA?
The inspection ran Dec 8, 2015 – Jan 15, 2016, and the Form 483 is dated January 15, 2016.
How do I get the full Form 483 for Making Cosmetics, Inc?
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.