Intrathecal Compounding Specialists, LLC
FDA inspection history across 3 sites, 2017 to 2022
- 3
- Form 483s
- 1
- Close-out
- 1
- Response
Every document, by year
- Close-out
- Form 483
- Response
2017: one Form 483; 2018: one 483 response; 2019: one Form 483; 2021: one Form 483; 2022: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–22Three Form 483s, one 483 response and one close-out letter, at Scott, Louisiana; Louisiana and Scot t, Louisiana.
- 2017The longest 483 on file: 14 observations over 6 pages at Scott, Louisiana.
Cited most
Across all Intrathecal Compounding Specialists observations on file
- FDCA 501(a)(2)(A)Insanitary conditions13
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.167Special testing requirements1
- 21 CFR 211.28Personnel responsibilities1
The complete Intrathecal Compounding Specialists file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Scott, Louisiana
Two Form 483s and one close-out letter · 2017 to 2022 · 19 observations
Latest: Close-out, Jan 19, 2022 →Scot t, Louisiana
One Form 483 · 2021 · 3 observations
Latest: Form 483, Aug 19, 2021 →Louisiana
One 483 response · 2018
Latest: Response, Jan 8, 2018 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-01-19 | Close-out Close-out letter | Scott, Louisiana | — | $99 |
| 2021-08-19 | 483 Form 483 | Scot t, Louisiana | 3 | $99 |
| 2019-02-14 | 483 Form 483 | Scott, Louisiana | 5 | $99 |
| 2018-01-08 | Response 483 response | Louisiana | — | $199 |
| 2017-11-17 | 483 Form 483 | Scott, Louisiana | 14 | $99 |
Investigators on these documents
FEI number 3006372310 · most recent document Jan 19, 2022
About Intrathecal Compounding Specialists, LLC
How many FDA Form 483s has Intrathecal Compounding Specialists, LLC received?
FDA Intel has 3 Form 483s on file for Intrathecal Compounding Specialists, LLC; the most recent is dated Aug 19, 2021.
When was Intrathecal Compounding Specialists, LLC last inspected by FDA?
The most recent FDA inspection document on file for Intrathecal Compounding Specialists, LLC is a Form 483 dated Aug 19, 2021, for the site in Scot t, Louisiana.
What did FDA cite at Intrathecal Compounding Specialists, LLC?
The regulations cited most in the observations on file for Intrathecal Compounding Specialists, LLC are FDCA 501(a)(2)(A) (Insanitary conditions), 13 times; 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times.