Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-11-05.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Nov 2019 | Foods & Cosmetics | Clean | |
| 12 Oct 2016 – 17 Oct 2016 | Human Drugs | Clean | |
| 4 Nov 2013 – 21 Nov 2013 | Human Drugs | 483 | View 483 → |
| 30 Aug 2011 | Not recorded | 483 | On file |
| 20 Nov 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Nov 2013
21 CFR 111.65
Quality control - quality, dietary supplement
Cited by Melba T Rivera Clavell
21 Nov 2013
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Melba T Rivera Clavell
21 Nov 2013
21 CFR 211.84(d)(2)
Testing Each Component for Conformity with Specs
Cited by Melba T Rivera Clavell
Investigators
FDA investigators tied to this site in the record.
Melba T Rivera Clavell2 insp.
Cary Greene1 insp.
Gianine E Delade1 insp.
Jose M Cayuela1 insp.
Alberto A Viciedo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Promeko, Inc.'s 2 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat