Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-08-26.
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 |
|---|---|---|---|
| 23 Aug 2021 – 26 Aug 2021 | Foods & Cosmetics | 483 | On file |
| 6 Aug 2018 – 14 Aug 2018 | Foods & Cosmetics | 483 | On file |
| 5 Dec 2016 – 29 Dec 2016 | Foods & Cosmetics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Aug 2021
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Joseph C Yen, Justin A Boyd
26 Aug 2021
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Joseph C Yen, Justin A Boyd
26 Aug 2021
21 CFR 111.123(a)(8)
Quality control - finished batch, distribution
Cited by Joseph C Yen, Justin A Boyd
26 Aug 2021
21 CFR 111.123(a)(8)
Quality control - finished batch, distribution
Cited by Joseph C Yen, Justin A Boyd
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(a)(8) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.320(a) | 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(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ascent America Laboratories 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