Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-16.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Nov 2022 – 16 Dec 2022 | Human Drugs | 483 | View 483 → |
| 1 Sep 2022 – 8 Sep 2022 | Foods & Cosmetics | 483 | View 483 → |
| 13 Nov 2017 – 4 Dec 2017 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Dec 2022
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Jennifer Lalama, Dorothy P Kramer
16 Dec 2022
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Jennifer Lalama, Dorothy P Kramer
16 Dec 2022
21 CFR 211.84(a)
Components withheld from use pending release
Cited by Jennifer Lalama, Dorothy P Kramer
16 Dec 2022
21 CFR 211.84(d)(2)
Establish reliability of supplier's C of A
Cited by Jennifer Lalama, Dorothy P Kramer
8 Sep 2022
21 CFR 111.117(a)
Quality control operations - calibrating processes
Cited by Ivis L Negron Torres, Benita C Okeke
Investigators
FDA investigators tied to this site in the record.
Jennifer Lalama1 insp.
Dorothy P Kramer1 insp.
Ivis L Negron Torres1 insp.
Benita C Okeke1 insp.
John J Bernal1 insp.
Sharon Giamberini1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.117(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.123(a)(7) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.30(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.315(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.23(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.430(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | 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 RAPHA Health Network International, Inc.'s 3 Form 483s
Source PDFs, 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