Apotheca, Inc.
Form 483 issued August 28, 2008 · STATE. ZIP CODE, Iowa
- Inspection
- Aug 19 – Aug 28, 2008
- Investigators
- Brent T. Hall· David L. Miser
- Observations
- 4
- Pages
- 5
- FEI number
- 1931484
In short: On August 28, 2008, FDA issued a Form 483 with 4 observations to Apotheca, Inc. in STATE. ZIP CODE, Iowa (FEI 1931484) after an inspection that ran Aug 19 – Aug 28, 2008. The investigators were Brent T. Hall and David L. Miser. Most observations concern production and materials.
At a glance
Production and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Each lot of components, drug product containers, and closures is not withheld from use until the…
- 03
Batch production and control records do not include the results of any investigation made into any…
- 04
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
This inspection in context
Brent T. Hall
1 document · 2008
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Iowa.
The firmApotheca, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apotheca, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, materials and quality system. The opening words of each observation are shown on this page.
Who inspected Apotheca, Inc.?
Brent T. Hall and David L. Miser are named on this Form 483, for the inspection of Aug 19 – Aug 28, 2008. Each investigator has a profile showing what they cite most.
When was Apotheca, Inc. inspected by FDA?
The inspection ran Aug 19 – Aug 28, 2008, and the Form 483 is dated August 28, 2008.
How do I get the full Form 483 for Apotheca, 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.