Specialty Compounding LLC
FDA inspection history in Cedar Park, Texas, 2013 to 2015
- 3
- Form 483s
Every document, by year
- Form 483
2013: two Form 483s; 2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–15Three Form 483s, at Cedar Park, Texas.
- 2013The longest 483 on file: 15 observations over 13 pages at Cedar Park, Texas.
Cited most
Across all Specialty Compounding observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.165(a)Testing and release for distribution3
- 21 CFR 211.42(c)(10)(iv)Design and construction features3
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.188Batch production and control records2
The complete Specialty Compounding file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Cedar Park, Texas
Three Form 483s · 2013 to 2015 · 28 observations
Latest: Form 483, May 5, 2015 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-05-05 | 483 Form 483 | Cedar Park, Texas | 5 | $99 |
| 2013-09-13 | 483 Form 483 | Cedar Park, Texas | 15 | $99 |
| 2013-03-22 | 483 Form 483 | Cedar Park, Texas | 8 | $99 |
Investigators on these documents
Jamillah Selby (1)Lucas B. Leake (1)Margaret M. Annes (1)Stephen D. Brown (1)
FEI number 3009815000 · most recent document May 5, 2015
About Specialty Compounding LLC
How many FDA Form 483s has Specialty Compounding LLC received?
FDA Intel has 3 Form 483s on file for Specialty Compounding LLC; the most recent is dated May 5, 2015.
When was Specialty Compounding LLC last inspected by FDA?
The most recent FDA inspection document on file for Specialty Compounding LLC is a Form 483 dated May 5, 2015, for the site in Cedar Park, Texas.
What did FDA cite at Specialty Compounding LLC?
The regulations cited most in the observations on file for Specialty Compounding LLC are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.165(a) (Testing and release for distribution), 3 times; 21 CFR 211.42(c)(10)(iv) (Design and construction features), 3 times.