Apothecure, Inc.
Amended 483 issued April 17, 2013 · Dallas, Texas
- Inspection
- Mar 18 – Apr 16, 2013
- Investigators
- Jamillah Selby· John T. Chapman· Stephen D. Brown
- Observations
- 13
- Pages
- 16
- FEI number
- 3000203232
In short: On April 17, 2013, FDA issued a Amended 483 with 13 observations to Apothecure, Inc. in Dallas, Texas (FEI 3000203232) after an inspection that ran Mar 18 – Apr 16, 2013. The investigators were Jamillah Selby, John T. Chapman and Stephen D. Brown. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
There is no written testing program designed to assess the stability…
- 04
Procedures describing the handling of all written and oral complaints regarding a drug…
9 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Jamillah Selby
7 documents · 2013–2024
Cites 211.42(c)(10)(iv) (design and construction features) 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 documentsOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Apothecure, Inc.?
FDA listed 13 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Apothecure, Inc.?
Jamillah Selby, John T. Chapman and Stephen D. Brown are named on this Amended 483, for the inspection of Mar 18 – Apr 16, 2013. Each investigator has a profile showing what they cite most.
When was Apothecure, Inc. inspected by FDA?
The inspection ran Mar 18 – Apr 16, 2013, and the Amended 483 is dated April 17, 2013.
How do I get the full Amended 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.