Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-03-14.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Feb 2022 – 14 Mar 2022 | Human Drugs | 483 | On file |
| 20 Aug 2018 – 24 Oct 2018 | Human Drugs | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Oct 2018
21 CFR 211.111
Establishment of time limitations
Cited by Nicholas L Paulin, Michael P Sheehan
24 Oct 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Nicholas L Paulin, Michael P Sheehan
24 Oct 2018
21 CFR 211.125(b)
Examination of issued labels
Cited by Nicholas L Paulin, Michael P Sheehan
24 Oct 2018
21 CFR 211.165(a)
Testing and release for distribution
Cited by Nicholas L Paulin, Michael P Sheehan
24 Oct 2018
21 CFR 211.166(a)
Lack of written stability program
Cited by Nicholas L Paulin, Michael P Sheehan
Investigators
FDA investigators tied to this site in the record.
Lauren N Howard1 insp.
Logan T Williams1 insp.
Lisa R Hilliard1 insp.
Nicholas L Paulin1 insp.
Michael P Sheehan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(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 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(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 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Tailor Made Compounding LLC's 2 Form 483s
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