Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-17.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Nov 2023 – 17 Nov 2023 | Human Drugs | Clean | |
| 10 Jan 2023 – 18 Jan 2023 | Human Drugs | Clean | |
| 17 Dec 2018 – 21 Dec 2018 | Human Drugs | 483 | On file |
| 27 Mar 2017 – 31 Mar 2017 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Dec 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Saleem A Akhtar
31 Mar 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Hala L Selby
31 Mar 2017
21 CFR 211.111
Establishment of time limitations
Cited by Hala L Selby
31 Mar 2017
21 CFR 211.180(b)
Record maintenance 1 year (except exempt OTC)
Cited by Hala L Selby
Investigators
FDA investigators tied to this site in the record.
Janet A Rajan1 insp.
Lisa L Flores1 insp.
Jill J Tillman1 insp.
Saleem A Akhtar1 insp.
Hala L Selby1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | 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 APL Healthcare Limited'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