Cape Apothecary Inc.
Form 483 issued December 2, 2021 · Annapolis, Maryland
- Inspection
- Nov 8 – Dec 2, 2021
- Investigators
- Kathleen M. Jordan· Sena G. Dissmeyer
- Observations
- 4
- Pages
- 4
- FEI number
- 3004562873
In short: On December 2, 2021, FDA issued a Form 483 with 4 observations to Cape Apothecary Inc. in Annapolis, Maryland (FEI 3004562873) after an inspection that ran Nov 8 – Dec 2, 2021. The investigators were Kathleen M. Jordan and Sena G. Dissmeyer. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 1 system, led by production.
Most cited: FDCA 501(a)(2)(A) (3×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were…
- 02FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had difficult to clean and…
- 03FDCA 501(a)(2)(A)
Your facility design allowed the influx of poor quality air into…
- 04
ISO 5 classified areas w ere not cert ified…
This inspection in context
Kathleen M. Jordan
6 documents · 2021–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmCape Apothecary Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cape Apothecary Inc.?
FDA listed 4 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Cape Apothecary Inc.?
Kathleen M. Jordan and Sena G. Dissmeyer are named on this Form 483, for the inspection of Nov 8 – Dec 2, 2021. Each investigator has a profile showing what they cite most.
When was Cape Apothecary Inc. inspected by FDA?
The inspection ran Nov 8 – Dec 2, 2021, and the Form 483 is dated December 2, 2021.
How do I get the full Form 483 for Cape Apothecary 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.