Eagle Analytical Services
Form 483 issued June 17, 2013 · Houston, Texas
- Inspection
- Jun 5 – Jun 17, 2013
- Investigators
- Andrea A. Branche· Patty P. Kaewussdangkul
- Observations
- 8
- Pages
- 7
- FEI number
- 3004549631
In short: On June 17, 2013, FDA issued a Form 483 with 8 observations to Eagle Analytical Services in Houston, Texas (FEI 3004549631) after an inspection that ran Jun 5 – Jun 17, 2013. The investigators were Andrea A. Branche and Patty P. Kaewussdangkul. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 7 of 8 observations.
Most cited: 21 CFR 211.160 (2×) · 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, and test…
- 02
Deviations from written specifications…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Laboratory records do not include the initials or signature of a second person showing that the…
This inspection in context
Andrea A. Branche
6 documents · 2009–2018
Cites 56.108(a)(1) (irb functions and operations) more than any other section. Most of their documents are for sites in Texas.
The firmEagle Analytical Services history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eagle Analytical Services?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Eagle Analytical Services?
Andrea A. Branche and Patty P. Kaewussdangkul are named on this Form 483, for the inspection of Jun 5 – Jun 17, 2013. Each investigator has a profile showing what they cite most.
When was Eagle Analytical Services inspected by FDA?
The inspection ran Jun 5 – Jun 17, 2013, and the Form 483 is dated June 17, 2013.
How do I get the full Form 483 for Eagle Analytical Services?
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.