Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-11.
At a glance
Inspections
7
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 – 11 Dec 2025 | Human Drugs | 483 | View 483 → |
| 6 Nov 2020 – 12 Nov 2020 | Human Drugs | 483 | View 483 → |
| 19 Apr 2017 – 21 Apr 2017 | Human Drugs | 483 | View 483 → |
| 27 Jun 2016 – 30 Jun 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Mar 2014 – 20 Mar 2014 | Medical Devices & Rad Health | Clean | |
| 13 Apr 2011 | Not recorded | Clean | |
| 24 Feb 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Dec 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Jeffrey P Raimondi, Anney Lin
11 Dec 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jeffrey P Raimondi, Anney Lin
11 Dec 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jeffrey P Raimondi, Anney Lin
11 Dec 2025
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jeffrey P Raimondi, Anney Lin
Investigators
FDA investigators tied to this site in the record.
Jocelyn E Massey2 insp.
Jeffrey P Raimondi1 insp.
Anney Lin1 insp.
Truong X Nguyen1 insp.
Yasamin Ameri1 insp.
Janet Pulver1 insp.
Minh D Phan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | 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 Life Science Outsourcing, Inc.'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