Beauty Manufacturing Solutions Corp.
Form 483 issued April 7, 2021 · Coppell, Texas
- Inspection
- Mar 30 – Apr 7, 2021
- Investigators
- Michelle A. Krayer· Patty P. Kaewussdangkul
- Observations
- 2
- Pages
- 3
- FEI number
- 1610490
In short: On April 7, 2021, FDA issued a Form 483 with 2 observations to Beauty Manufacturing Solutions Corp. in Coppell, Texas (FEI 1610490) after an inspection that ran Mar 30 – Apr 7, 2021. The investigators were Michelle A. Krayer and Patty P. Kaewussdangkul. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22(a) (1×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to fully investigate…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Michelle A. Krayer
11 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Texas.
The firmBeauty Manufacturing Solutions Corp. 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(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Beauty Manufacturing Solutions Corp.?
FDA listed 2 observations on this Form 483, mostly about quality system 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 Beauty Manufacturing Solutions Corp.?
Michelle A. Krayer and Patty P. Kaewussdangkul are named on this Form 483, for the inspection of Mar 30 – Apr 7, 2021. Each investigator has a profile showing what they cite most.
When was Beauty Manufacturing Solutions Corp. inspected by FDA?
The inspection ran Mar 30 – Apr 7, 2021, and the Form 483 is dated April 7, 2021.
How do I get the full Form 483 for Beauty Manufacturing Solutions Corp.?
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