Specialty Compounding LLC
Form 483 issued September 13, 2013 · Cedar Park, Texas
- Inspection
- Aug 13 – Sep 13, 2013
- Investigator
- Jamillah Selby
- Observations
- 15
- Pages
- 13
- FEI number
- 3009815000
In short: On September 13, 2013, FDA issued a Form 483 with 15 observations to Specialty Compounding LLC in Cedar Park, Texas (FEI 3009815000) after an inspection that ran Aug 13 – Sep 13, 2013. The investigator was Jamillah Selby. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 9 of 15 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Drug product production and control records, are not reviewed and approved by the quality control unit…
This inspection in context
Jamillah Selby
7 documents · 2013–2024
Cites 211.42(c)(10)(iv) (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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Specialty Compounding LLC?
FDA listed 15 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Specialty Compounding LLC?
Jamillah Selby is named on this Form 483, for the inspection of Aug 13 – Sep 13, 2013. Each investigator has a profile showing what they cite most.
When was Specialty Compounding LLC inspected by FDA?
The inspection ran Aug 13 – Sep 13, 2013, and the Form 483 is dated September 13, 2013.
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.