Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-17.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2024 – 17 Sep 2024 | Human Drugs | WL | View 483 → |
| 10 Oct 2019 – 18 Oct 2019 | Human Drugs | Clean | |
| 26 Nov 2018 – 4 Dec 2018 | Human Drugs | 483 | View 483 → |
| 11 Apr 2016 – 19 Apr 2016 | Human Drugs | 483 | View 483 → |
| 19 May 2014 – 23 May 2014 | Human Drugs | Clean | |
| 17 May 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Sep 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Justin A Boyd, Josh Renzo N Ramilo, JoshRenzo N Ramilo
17 Sep 2024
21 CFR 211.111
Establishment of time limitations
Cited by Justin A Boyd, Josh Renzo N Ramilo, JoshRenzo N Ramilo
17 Sep 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Justin A Boyd, Josh Renzo N Ramilo, JoshRenzo N Ramilo
17 Sep 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Justin A Boyd, Josh Renzo N Ramilo, JoshRenzo N Ramilo
17 Sep 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Justin A Boyd, Josh Renzo N Ramilo, JoshRenzo N Ramilo
Investigators
FDA investigators tied to this site in the record.
Justin A Boyd1 insp.
Josh Renzo N Ramilo1 insp.
JoshRenzo N Ramilo1 insp.
Truong X Nguyen1 insp.
Michael Shanks1 insp.
Cheryl A Clausen1 insp.
Jose A Cruz Gonzalez1 insp.
Steven D Kehoe1 insp.
James C Maclaughlin1 insp.
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 | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | 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 211.42(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 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ASPEN SA STERILE OPERATIONS (PTY) LTD's 3 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