Specialty Compounding LLC
Form 483 issued May 5, 2015 · Cedar Park, Texas
- Inspection
- Mar 23 – May 5, 2015
- Investigator
- Stephen D. Brown
- Observations
- 5
- Pages
- 3
- FEI number
- 3009815000
In short: On May 5, 2015, FDA issued a Form 483 with 5 observations to Specialty Compounding LLC in Cedar Park, Texas (FEI 3009815000) after an inspection that ran Mar 23 – May 5, 2015. The investigator was Stephen D. Brown. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm has faikJ l\) establish aJ~quJtt: prot..:edures for condu..:ting appropr iate media…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Your firm has not established adequate written Standard Operating Procedures to ensure proper maintenance of aseptic…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmSpecialty Compounding LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Specialty Compounding LLC?
FDA listed 5 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Specialty Compounding LLC?
Stephen D. Brown is named on this Form 483, for the inspection of Mar 23 – May 5, 2015. Each investigator has a profile showing what they cite most.
When was Specialty Compounding LLC inspected by FDA?
The inspection ran Mar 23 – May 5, 2015, and the Form 483 is dated May 5, 2015.
How do I get the full Form 483 for Specialty Compounding LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.