Specialty Compounding LLC
Form 483 issued March 22, 2013 · Cedar Park, Texas
- Inspection
- Mar 18 – Mar 22, 2013
- Investigators
- Lucas B. Leake· Margaret M. Annes
- Observations
- 8
- Pages
- 6
- FEI number
- 3009815000
In short: On March 22, 2013, FDA issued a Form 483 with 8 observations to Specialty Compounding LLC in Cedar Park, Texas (FEI 3009815000) after an inspection that ran Mar 18 – Mar 22, 2013. The investigators were Lucas B. Leake and Margaret M. Annes. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 6 of 8 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Lucas B. Leake
8 documents · 2012–2019
Cites 211.42 (design and construction features) 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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Specialty Compounding LLC?
FDA listed 8 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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?
Lucas B. Leake and Margaret M. Annes are named on this Form 483, for the inspection of Mar 18 – Mar 22, 2013. Each investigator has a profile showing what they cite most.
When was Specialty Compounding LLC inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2013, and the Form 483 is dated March 22, 2013.
How do I get the full Form 483 for Specialty Compounding LLC?
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