Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-07-18.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jul 2018 – 18 Jul 2018 | Human Drugs | WL | View 483 → |
| 22 Feb 2016 – 26 Feb 2016 | Human Drugs | 483 | View 483 → |
| 7 Feb 2012 | Not recorded | 483 | View 483 → |
| 7 Aug 2009 | Not recorded | 483 | View 483 → |
| 26 Jul 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Jul 2018
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Tajah L Blackburn, Gideon N Esuzor
18 Jul 2018
21 CFR 211.166(a)
Lack of written stability program
Cited by Tajah L Blackburn, Gideon N Esuzor
18 Jul 2018
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Tajah L Blackburn, Gideon N Esuzor
18 Jul 2018
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Tajah L Blackburn, Gideon N Esuzor
26 Feb 2016
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Jessica L Pressley, Ileana Barreto-Pettit
Investigators
FDA investigators tied to this site in the record.
Ileana Barreto-Pettit3 insp.
Tajah L Blackburn1 insp.
Gideon N Esuzor1 insp.
Jessica L Pressley1 insp.
Ethan P Stegman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | 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)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Andapharm, LLC's 4 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