Chemolee Lab Corporation
Form 483 issued February 13, 2015 · Irving, Texas
- Inspection
- Jan 12 – Feb 13, 2015
- Investigators
- Alan P. Kurtzberg· Elisa M. Fleming· Lisa R. Jennings
- Observations
- 13
- Pages
- 9
- FEI number
- 1642813
In short: On February 13, 2015, FDA issued a Form 483 with 13 observations to Chemolee Lab Corporation in Irving, Texas (FEI 1642813) after an inspection that ran Jan 12 – Feb 13, 2015. The investigators were Alan P. Kurtzberg, Elisa M. Fleming and Lisa R. Jennings. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 9 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Procedures describing the handling of all written and oral complaints regarding a drug product are…
- 03
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 04
Investigations of a failure of a batch or any of its components to meet any of…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmChemolee Lab Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chemolee Lab Corporation?
FDA listed 13 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Chemolee Lab Corporation?
Alan P. Kurtzberg, Elisa M. Fleming and Lisa R. Jennings are named on this Form 483, for the inspection of Jan 12 – Feb 13, 2015. Each investigator has a profile showing what they cite most.
When was Chemolee Lab Corporation inspected by FDA?
The inspection ran Jan 12 – Feb 13, 2015, and the Form 483 is dated February 13, 2015.
How do I get the full Form 483 for Chemolee Lab Corporation?
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