Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-07-30.
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 |
|---|---|---|---|
| 23 Jul 2018 – 30 Jul 2018 | Human Drugs | 483 | On file |
| 6 Jun 2016 – 17 Jun 2016 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jun 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Anthony J Ladner, James K Ireland, Gregory A Berg
17 Jun 2016
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Anthony J Ladner, James K Ireland, Gregory A Berg
17 Jun 2016
21 CFR 211.165(d)
Acceptance criteria for sampling & testing
Cited by Anthony J Ladner, James K Ireland, Gregory A Berg
17 Jun 2016
21 CFR 211.166(a)
Lack of written stability program
Cited by Anthony J Ladner, James K Ireland, Gregory A Berg
17 Jun 2016
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Anthony J Ladner, James K Ireland, Gregory A Berg
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)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | 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 211.42(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 |
Full site report
Get the verbatim findings behind W & C dba The Apothecary's 2 Form 483s
Source PDFs, 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