Miramar Cosmetics, Inc DBA Miramar Lab
Form 483 issued August 31, 2022 · Doral, Florida
- Inspection
- Aug 29 – Aug 31, 2022
- Investigators
- Benita C. Okeke· Ivis L. Negron Torres
- Observations
- 8
- Pages
- 4
- FEI number
- 3004486512
In short: On August 31, 2022, FDA issued a Form 483 with 8 observations to Miramar Cosmetics, Inc DBA Miramar Lab in Doral, Florida (FEI 3004486512) after an inspection that ran Aug 29 – Aug 31, 2022. The investigators were Benita C. Okeke and Ivis L. Negron Torres. Most observations concern dietary supplement CGMP.
At a glance
8 of 8 observations on this 483 concern dietary supplement cgmp.
What FDA observed
Preview: the opening words of each observation- 01
Personnel engaged in packaging, labeling and holding dietary supplements do not have the education, training, or…
- 02
You did not establish written procedures…
- 0321 CFR 111.430(b)
You did not make and keep records of the written procedures for…
- 0421 CFR 111.180(b)(1)
EMPLOYEE{S) SIGNATURE You did not make and keep written procedures for fulfilling the requirements that apply…
This inspection in context
Benita C. Okeke
2 documents · 2022–2023
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in Florida.
The firmMiramar Cosmetics, Inc DBA Miramar Lab history
The site's inspection history, in date order.
Similar 483sOther sites cited under 111.12(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Miramar Cosmetics, Inc DBA Miramar Lab?
FDA listed 8 observations on this Form 483, mostly about dietary supplement CGMP. The opening words of each observation are shown on this page.
Who inspected Miramar Cosmetics, Inc DBA Miramar Lab?
Benita C. Okeke and Ivis L. Negron Torres are named on this Form 483, for the inspection of Aug 29 – Aug 31, 2022. Each investigator has a profile showing what they cite most.
When was Miramar Cosmetics, Inc DBA Miramar Lab inspected by FDA?
The inspection ran Aug 29 – Aug 31, 2022, and the Form 483 is dated August 31, 2022.
How do I get the full Form 483 for Miramar Cosmetics, Inc DBA Miramar Lab?
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.