Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-12-06.
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 |
|---|---|---|---|
| 1 Nov 2016 – 6 Dec 2016 | Human Drugs | 483 | View 483 → |
| 2 Apr 2015 | Human Drugs | Clean | |
| 2 Mar 2015 – 10 Mar 2015 | Human Drugs | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Rajiv R Srivastava, Chad N Thompson
6 Dec 2016
21 CFR 211.166(a)
Lack of written stability program
Cited by Rajiv R Srivastava, Chad N Thompson
6 Dec 2016
21 CFR 211.167(a)
Sterility/pyrogen-free testing
Cited by Rajiv R Srivastava, Chad N Thompson
6 Dec 2016
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Rajiv R Srivastava, Chad N Thompson
6 Dec 2016
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Rajiv R Srivastava, Chad N Thompson
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 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(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) | 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 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fallon Wellness Pharmacy, L.L.C.'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