Overview
- 24 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
31 Aug 2022
21 CFR 111.103
Written procedures - quality control operations
Cited by Ivis L Negron Torres, Benita C Okeke
31 Aug 2022
21 CFR 111.103
Written procedures - quality control operations
Cited by Ivis L Negron Torres, Benita C Okeke
31 Aug 2022
21 CFR 111.12(c)
Personnel - education, training, experience
Cited by Ivis L Negron Torres, Benita C Okeke
31 Aug 2022
21 CFR 111.12(c)
Personnel - education, training, experience
Cited by Ivis L Negron Torres, Benita C Okeke
31 Aug 2022
21 CFR 111.180(b)(1)
Written procedures - product received
Cited by Ivis L Negron Torres, Benita C Okeke
Inspected site
MCMiramar Cosmetics, Inc DBA Miramar LabDoral, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.12(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.180(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.430(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 3x |
Source document
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PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 24 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere