Apothecure, Inc.
Form 483 issued August 13, 2007 · Dallas, Texas
- Inspection
- Aug 6 – Aug 13, 2007
- Investigator
- Jean M. Cook
- Observations
- 13
- Pages
- 7
- FEI number
- 3000203232
In short: On August 13, 2007, FDA issued a Form 483 with 13 observations to Apothecure, Inc. in Dallas, Texas (FEI 3000203232) after an inspection that ran Aug 6 – Aug 13, 2007. The investigator was Jean M. Cook. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 8 of 13 observations.
Most cited: 21 CFR 211.113 (2×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Jean M. Cook
1 document · 2007
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmApothecure, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apothecure, Inc.?
FDA listed 13 observations on this Form 483, mostly about production, laboratory controls and materials. 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 Apothecure, Inc.?
Jean M. Cook is named on this Form 483, for the inspection of Aug 6 – Aug 13, 2007. Each investigator has a profile showing what they cite most.
When was Apothecure, Inc. inspected by FDA?
The inspection ran Aug 6 – Aug 13, 2007, and the Form 483 is dated August 13, 2007.
How do I get the full Form 483 for Apothecure, Inc.?
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.