Apotheca, Inc.
Form 483 issued July 14, 2021 · Woodbine, Iowa
- Inspection
- Jul 7 – Jul 14, 2021
- Observations
- 5
- Pages
- 7
- FEI number
- 1931484
In short: On July 14, 2021, FDA issued a Form 483 with 5 observations to Apotheca, Inc. in Woodbine, Iowa (FEI 1931484) after an inspection that ran Jul 7 – Jul 14, 2021. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The calibration of instruments is not…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 04
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Questions about this 483
What did FDA find at Apotheca, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
When was Apotheca, Inc. inspected by FDA?
The inspection ran Jul 7 – Jul 14, 2021, and the Form 483 is dated July 14, 2021.
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.