Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-08-25.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Aug 2020 – 25 Aug 2020 | Foods & Cosmetics | Clean | |
| 31 Jan 2017 – 6 Feb 2017 | Foods & Cosmetics | Clean | |
| 16 Dec 2013 – 17 Dec 2013 | Foods & Cosmetics | Clean | |
| 13 May 2011 | Not recorded | 483 | View 483 → |
| 30 Oct 2008 | Not recorded | 483 | View 483 → |
| 26 Nov 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 May 2011
21 CFR 114.100(b)
Maintenance of processing and production records
Cited by Seng-Ching Hwang
30 Oct 2008
21 CFR 110.80(b)(13)
Filling, assembling, packing controls
Cited by Raymond L Cheung, Hitesh R Patel
Investigators
FDA investigators tied to this site in the record.
Carol A Robles1 insp.
Teigan M Mule1 insp.
Michael Rosner1 insp.
Jo-Ann C Declement1 insp.
Seng-Ching Hwang1 insp.
Raymond L Cheung1 insp.
Hitesh R Patel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.83 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Chelten House Products, 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