Celltex Therapeutics Corporation
Form 483 issued April 27, 2012 · Sugarland, Texas
- Inspection
- Apr 16 – Apr 27, 2012
- Investigators
- Joel Martinez· Linda M. Hoover
- Observations
- 14
- Pages
- 9
- FEI number
- 3009499974
In short: On April 27, 2012, FDA issued a Form 483 with 14 observations to Celltex Therapeutics Corporation in Sugarland, Texas (FEI 3009499974) after an inspection that ran Apr 16 – Apr 27, 2012. The investigators were Joel Martinez and Linda M. Hoover. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.192 (2×) · 211.80(d) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Written records are not made of investigations into the failure of a batch or any ofits…
- 04
Drug product production and control records, are not reviewed by the quality control unit to determine…
This inspection in context
Joel Martinez
7 documents · 2002–2014
Cites 211.80(a) (general requirements) more than any other section. Most of their documents are for sites in Texas.
The firmCelltex Therapeutics Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Celltex Therapeutics Corporation?
FDA listed 14 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Celltex Therapeutics Corporation?
Joel Martinez and Linda M. Hoover are named on this Form 483, for the inspection of Apr 16 – Apr 27, 2012. Each investigator has a profile showing what they cite most.
When was Celltex Therapeutics Corporation inspected by FDA?
The inspection ran Apr 16 – Apr 27, 2012, and the Form 483 is dated April 27, 2012.
How do I get the full Form 483 for Celltex Therapeutics Corporation?
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.