Cape Apothecary Inc.
FDA inspection history across 2 sites, 2015 to 2022
- 3
- Form 483s
- 2
- Responses
- 1
- Untitled letter
- 1
- Warning letter
Every document, by year
- Response
- Untitled letter
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2018: one Form 483; 2021: one Form 483; 2022: two untitled letter responses and one untitled letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two Form 483s and one warning letter, at Annapolis, Maryland.
- 2015The longest 483 on file: 11 observations over 6 pages at Annapolis, Maryland.
- 2021–22Two untitled letter responses, one Form 483 and one untitled letter, at Annapolis, Maryland and Maryland.
Cited most
Across all Cape Apothecary observations on file
- 21 CFR 211.113Control of microbiological contamination3
- FDCA 501(a)(2)(A)Insanitary conditions3
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
The complete Cape Apothecary file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Annapolis, Maryland
Three Form 483s, one untitled letter and one warning letter · 2015 to 2022 · 18 observations
Latest: Untitled letter, Jul 20, 2022 →Maryland
Two untitled letter responses · 2022
Latest: Response, Nov 3, 2022 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-03 | Response Untitled letter response | Maryland | — | $199 |
| 2022-08-31 | Response Untitled letter response | Maryland | — | $199 |
| 2022-07-20 | Untitled letter Untitled letter | Annapolis, Maryland | — | $99 |
| 2021-12-02 | 483 Form 483 | Annapolis, Maryland | 4 | $99 |
| 2018-01-22 | 483 Form 483 | Annapolis, Maryland | 3 | $99 |
| 2016-08-12 | Warning letter Warning letter | Annapolis, Maryland | — | $99 |
| 2015-10-07 | 483 Form 483 | Annapolis, Maryland | 11 | $99 |
Investigators on these documents
Kathleen M. Jordan (1)Nebil A. Oumer (1)Qin Xu (1)Sena G. Dissmeyer (1)Zakaria I. Ganiyu (1)
FEI number 3004562873 · most recent document Nov 3, 2022
About Cape Apothecary Inc.
How many FDA Form 483s has Cape Apothecary Inc. received?
FDA Intel has 3 Form 483s on file for Cape Apothecary Inc.; the most recent is dated Dec 2, 2021.
When was Cape Apothecary Inc. last inspected by FDA?
The most recent FDA inspection document on file for Cape Apothecary Inc. is a Form 483 dated Dec 2, 2021, for the site in Annapolis, Maryland.
What did FDA cite at Cape Apothecary Inc.?
The regulations cited most in the observations on file for Cape Apothecary Inc. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; FDCA 501(a)(2)(A) (Insanitary conditions), 3 times; 21 CFR 211.42 (Design and construction features), 2 times.
Has Cape Apothecary Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Cape Apothecary Inc.; the most recent is dated Aug 12, 2016.
Has Cape Apothecary Inc. received an FDA untitled letter?
Yes. FDA Intel has 1 FDA untitled letter on file for Cape Apothecary Inc.; the most recent is dated Jul 20, 2022. An untitled letter is FDA's enforcement letter for violations that don't rise to warning-letter level.