Custom Compounding Centers, LLC
Form 483 issued December 13, 2012 · Los Alamitos, California
- Inspection
- Dec 13, 2012
- Investigator
- Binh T. Nguyen
- Observations
- 14
- Pages
- 5
- FEI number
- 3009855773
In short: On December 13, 2012, FDA issued a Form 483 with 14 observations to Custom Compounding Centers, LLC in Los Alamitos, California (FEI 3009855773) after an inspection that ran Dec 13, 2012. The investigator was Binh T. Nguyen. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Laboratory controls and production account for 8 of 11 observations.
Most cited: 21 CFR 211.113 (4×) · 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The following sterile injectable drug products were rejected and destroyed along with their batch records for…
- 02
Observation 2: scanned text, readable in the full document.
- 03
The firm allows employees to enter ISO 5 areas wearing street clothes underneath a non-sterile gown…
- 04
The firm did not review, approved, reject, or comment on whether bacterial and fungal air results…
This inspection in context
Binh T. Nguyen
13 documents · 2009–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmCustom Compounding Centers, LLC history
All 8 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 Custom Compounding Centers, LLC?
FDA listed 14 observations on this Form 483, mostly about laboratory controls, production 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 Custom Compounding Centers, LLC?
Binh T. Nguyen is named on this Form 483, for the inspection of Dec 13, 2012. Each investigator has a profile showing what they cite most.
When was Custom Compounding Centers, LLC inspected by FDA?
The inspection ran Dec 13, 2012, and the Form 483 is dated December 13, 2012.
How do I get the full Form 483 for Custom Compounding Centers, 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.