Apotheca, Inc.
Form 483 issued July 14, 2022 · Woodbine, Iowa
- Inspection
- Jun 27 – Jul 14, 2022
- Investigators
- Eric T. Huebler· Lisa L. Flores
- Observations
- 7
- Pages
- 9
- FEI number
- 1931484
In short: On July 14, 2022, FDA issued a Form 483 with 7 observations to Apotheca, Inc. in Woodbine, Iowa (FEI 1931484) after an inspection that ran Jun 27 – Jul 14, 2022. The investigators were Eric T. Huebler and Lisa L. Flores. Most observations concern facilities & equipment and production.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
- 03
Adequate written procedures are not established for production and process controls designed to assure that the…
- 04
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
This inspection in context
Eric T. Huebler
1 document · 2022
Cites 211.100 (written procedures; deviations) 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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apotheca, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Apotheca, Inc.?
Eric T. Huebler and Lisa L. Flores are named on this Form 483, for the inspection of Jun 27 – Jul 14, 2022. Each investigator has a profile showing what they cite most.
When was Apotheca, Inc. inspected by FDA?
The inspection ran Jun 27 – Jul 14, 2022, and the Form 483 is dated July 14, 2022.
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.