Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-06-04.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 May 2021 – 4 Jun 2021 | Foods & Cosmetics | 483 | View 483 → |
| 10 May 2019 – 21 May 2019 | Foods & Cosmetics | WL | View 483 → |
| 29 Jun 2016 | Foods & Cosmetics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Jun 2021
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Alexandra B Pitkin
4 Jun 2021
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Alexandra B Pitkin
4 Jun 2021
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Alexandra B Pitkin
4 Jun 2021
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Alexandra B Pitkin
4 Jun 2021
21 CFR 111.205(a)
Master manufacturing record - unique formulation
Cited by Alexandra B Pitkin
Investigators
FDA investigators tied to this site in the record.
Alexandra B Pitkin2 insp.
Michael P Dimaano1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260(k)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.83(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ibitta Enterprises, 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