Cape Apothecary Inc.
Form 483 issued January 22, 2018 · Annapolis, Maryland
- Inspection
- Jan 2, 2018
- Investigator
- Zakaria I. Ganiyu
- Observations
- 3
- Pages
- 3
- FEI number
- 3004562873
In short: On January 22, 2018, FDA issued a Form 483 with 3 observations to Cape Apothecary Inc. in Annapolis, Maryland (FEI 3004562873) after an inspection that ran Jan 2, 2018. The investigator was Zakaria I. Ganiyu. Most observations concern facilities & equipment and materials.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Specific identification tests are not conducted on components that have been accepted based on the…
This inspection in context
Zakaria I. Ganiyu
5 documents · 2016–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cape Apothecary Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Cape Apothecary Inc.?
Zakaria I. Ganiyu is named on this Form 483, for the inspection of Jan 2, 2018. Each investigator has a profile showing what they cite most.
When was Cape Apothecary Inc. inspected by FDA?
The inspection ran Jan 2, 2018, and the Form 483 is dated January 22, 2018.
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.