Apotheca, Inc.
FDA inspection history across 2 sites, 2008 to 2022
- 4
- Form 483s
Every document, by year
- Form 483
2008: one Form 483; 2019: one Form 483; 2021: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2008One Form 483, at STATE. ZIP CODE, Iowa.
- 2019–22Three Form 483s, at Woodbine, Iowa.
- 2022The longest 483 on file: 7 observations over 9 pages at Woodbine, Iowa.
Cited most
Across all Apotheca observations on file
- 21 CFR 211.165Testing and release for distribution4
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.160General requirements2
The complete Apotheca file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Woodbine, Iowa
Three Form 483s · 2019 to 2022 · 18 observations
Latest: Form 483, Jul 14, 2022 →STATE. ZIP CODE, Iowa
One Form 483 · 2008 · 4 observations
Latest: Form 483, Aug 28, 2008 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-14 | 483 Form 483 | Woodbine, Iowa | 7 | $99 |
| 2021-07-14 | 483 Form 483 | Woodbine, Iowa | 5 | $99 |
| 2019-12-06 | 483 Form 483 | Woodbine, Iowa | 6 | $99 |
| 2008-08-28 | 483 Form 483 | STATE. ZIP CODE, Iowa | 4 | $99 |
Investigators on these documents
Brent T. Hall (1)David L. Miser (1)Emilie Kahn (1)Eric T. Huebler (1)Jacob G. Lutz (1)Lisa L. Flores (1)
FEI number 1931484 · most recent document Jul 14, 2022
About Apotheca, Inc.
How many FDA Form 483s has Apotheca, Inc. received?
FDA Intel has 4 Form 483s on file for Apotheca, Inc.; the most recent is dated Jul 14, 2022.
When was Apotheca, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Apotheca, Inc. is a Form 483 dated Jul 14, 2022, for the site in Woodbine, Iowa.
What did FDA cite at Apotheca, Inc.?
The regulations cited most in the observations on file for Apotheca, Inc. are 21 CFR 211.165 (Testing and release for distribution), 4 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 3 times.