Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-03-08.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2024 – 8 Mar 2024 | Biologics | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Mar 2024
21 CFR 211.110(a)
Written in-process control procedures
Cited by Emily B Camire, Richard L Bartlett
8 Mar 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Emily B Camire, Richard L Bartlett
8 Mar 2024
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Emily B Camire, Richard L Bartlett
8 Mar 2024
21 CFR 211.165(a)
Testing and release for distribution
Cited by Emily B Camire, Richard L Bartlett
Investigators
FDA investigators tied to this site in the record.
Emily B Camire1 insp.
Richard L Bartlett1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.196 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Frontier Biologics LLC's 1 Form 483
Source PDFs 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