Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
26 Feb 2018
21 CFR 111.103
Written procedures - quality control operations
Cited by Omayra N Rodriguez-Ruiz
26 Feb 2018
21 CFR 111.105(b)
Quality control - supplier qualification
Cited by Omayra N Rodriguez-Ruiz
26 Feb 2018
21 CFR 111.113
Quality control operations - material review, disposition
Cited by Omayra N Rodriguez-Ruiz
26 Feb 2018
21 CFR 111.535(b)(1)
Records - returned dietary supplement: written procedures
Cited by Omayra N Rodriguez-Ruiz
Inspected site
EIEmceta International, Inc.Doral, 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 | 1x |
| 21 CFR 111.105(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 observations
Every observation in full, 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