Flawless Beauty LLC
Form 483 issued January 10, 2018 · Ocean, New Jersey
- Inspection
- Nov 20, 2017 – Jan 10, 2018
- Investigators
- James R. Birkenstamm· Jessica M. Monteiro· William J. Muszynski
- Observations
- 8
- Pages
- 8
- FEI number
- 3010116206
In short: On January 10, 2018, FDA issued a Form 483 with 8 observations to Flawless Beauty LLC in Ocean, New Jersey (FEI 3010116206) after an inspection that ran Nov 20, 2017 – Jan 10, 2018. The investigators were James R. Birkenstamm, Jessica M. Monteiro and William J. Muszynski. Most observations concern quality system and materials.
At a glance
5 of 8 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviation from the procedural requirements of…
- 02
There is no quality…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug…
- 04
The distribution system is deficient in that each lot of drug product cannot be readily determined…
This inspection in context
James R. Birkenstamm
12 documents · 2018–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmFlawless Beauty LLC history
The site's inspection history, in date order.
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 Flawless Beauty LLC?
FDA listed 8 observations on this Form 483, mostly about quality system, materials and production. The opening words of each observation are shown on this page.
Who inspected Flawless Beauty LLC?
James R. Birkenstamm, Jessica M. Monteiro and William J. Muszynski are named on this Form 483, for the inspection of Nov 20, 2017 – Jan 10, 2018. Each investigator has a profile showing what they cite most.
When was Flawless Beauty LLC inspected by FDA?
The inspection ran Nov 20, 2017 – Jan 10, 2018, and the Form 483 is dated January 10, 2018.
How do I get the full Form 483 for Flawless Beauty 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.