Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-07-27.
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 |
|---|---|---|---|
| 10 Jul 2017 – 27 Jul 2017 | Human Drugs | 483 | On file |
| 12 May 2015 – 22 May 2015 | Human Drugs | WL | View 483 → |
| 30 Aug 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 May 2015
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Eric M Mueller, Joseph R Lambert
22 May 2015
21 CFR 211.160(b)(3)
Drug products-sampling procedures/specifications
Cited by Eric M Mueller, Joseph R Lambert
22 May 2015
21 CFR 211.166(a)
Lack of written stability program
Cited by Eric M Mueller, Joseph R Lambert
22 May 2015
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Eric M Mueller, Joseph R Lambert
22 May 2015
21 CFR 211.198(b)(1)
Written complaint record must include
Cited by Eric M Mueller, Joseph R Lambert
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 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | 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 211.198(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(c) | 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 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Essential Pharmacy Compounding'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