Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-17.
At a glance
Inspections
9
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Dec 2025 – 17 Dec 2025 | Human Drugs | 483 | View 483 → |
| 13 Sep 2023 – 19 Sep 2023 | Human Drugs | 483 | View 483 → |
| 24 Feb 2020 – 28 Feb 2020 | Human Drugs | 483 | View 483 → |
| 4 Nov 2019 – 8 Nov 2019 | Human Drugs | 483 | View 483 → |
| 15 Apr 2019 – 19 Apr 2019 | Human Drugs | Clean | |
| 18 Mar 2019 – 20 Mar 2019 | Human Drugs | Clean | |
| 22 Oct 2018 – 26 Oct 2018 | Human Drugs | Clean | |
| 20 Nov 2017 – 24 Nov 2017 | Human Drugs | Clean | |
| 15 May 2017 – 18 May 2017 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Dec 2025
21 CFR 211.198(b)(2)
Complaint Investigation/Follow-Up Findings
Cited by Guerlain Ulysse, Rafeeq A Habeeb
17 Dec 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Guerlain Ulysse, Rafeeq A Habeeb
17 Dec 2025
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Guerlain Ulysse, Rafeeq A Habeeb
17 Dec 2025
21 CFR 211.67(b)(4)
Cleaning SOPs/equipment identification
Cited by Guerlain Ulysse, Rafeeq A Habeeb
Investigators
FDA investigators tied to this site in the record.
Guerlain Ulysse1 insp.
Rafeeq A Habeeb1 insp.
Kellia N Hicks1 insp.
Farhana Khan1 insp.
Alan P Kurtzberg1 insp.
Truong X Nguyen1 insp.
Sateesh Kum Sathigari1 insp.
Gajendiran Mahadevan1 insp.
Sachinkumar V Patel1 insp.
Unnee Ranjan1 insp.
Nadeem I Chaudhry1 insp.
Satheesh Thomas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind APL HEALTHCARE LIMITED's 4 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