Apotheca, Inc.
Form 483 issued December 6, 2019 · Woodbine, Iowa
- Inspection
- Dec 2 – Dec 6, 2019
- Investigators
- Emilie Kahn· Jacob G. Lutz
- Observations
- 6
- Pages
- 9
- FEI number
- 1931484
In short: On December 6, 2019, FDA issued a Form 483 with 6 observations to Apotheca, Inc. in Woodbine, Iowa (FEI 1931484) after an inspection that ran Dec 2 – Dec 6, 2019. The investigators were Emilie Kahn and Jacob G. Lutz. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, sensitivity, specificity and reproducibility of test methods…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Representative samples are not taken of each shipment of each lot of components…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
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 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apotheca, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Apotheca, Inc.?
Emilie Kahn and Jacob G. Lutz are named on this Form 483, for the inspection of Dec 2 – Dec 6, 2019. Each investigator has a profile showing what they cite most.
When was Apotheca, Inc. inspected by FDA?
The inspection ran Dec 2 – Dec 6, 2019, and the Form 483 is dated December 6, 2019.
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.