Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-25.
At a glance
Inspections
11
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Aug 2023 – 25 Aug 2023 | Human Drugs | 483 | View 483 → |
| 4 Sep 2018 – 7 Sep 2018 | Human Drugs | Clean | |
| 11 Jul 2017 – 25 Jul 2017 | Human Drugs | 483 | On file |
| 27 May 2015 – 4 Jun 2015 | Human Drugs | 483 | View 483 → |
| 27 May 2011 | Not recorded | 483 | On file |
| 6 Aug 2010 | Not recorded | 483 | On file |
| 26 Feb 2010 | Not recorded | 483 | View 483 → |
| 24 Jul 2008 | Not recorded | Clean | |
| 2 May 2006 | Not recorded | Clean | |
| 17 Feb 2005 | Not recorded | Clean | |
| 14 Jan 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Aug 2023
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Margaret M Annes, Rodney L Tinzie
25 Aug 2023
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Margaret M Annes, Rodney L Tinzie
25 Aug 2023
21 CFR 211.84(d)(2)
Establish reliability of supplier's C of A
Cited by Margaret M Annes, Rodney L Tinzie
25 Aug 2023
21 CFR 211.84(d)(2)
Establish reliability of supplier's C of A
Cited by Margaret M Annes, Rodney L Tinzie
4 Jun 2015
21 CFR 211.68(b)
Computer control of master formula records
Cited by Linda Thai, Theresa Kirkham, Linda L Ng
Investigators
FDA investigators tied to this site in the record.
Stephen D Brown3 insp.
Margaret M Annes1 insp.
Rodney L Tinzie1 insp.
Jason R Caballero1 insp.
Lisa R Whitt1 insp.
Chunsheng Cai1 insp.
Linda Thai1 insp.
Theresa Kirkham1 insp.
Linda L Ng1 insp.
Anh Lac1 insp.
Latrecia D Stubbs1 insp.
State Agency1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Neos Therapeutics, LP's 6 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