Cape Apothecary Inc.
Form 483 issued October 7, 2015 · Annapolis, Maryland
- Inspection
- Sep 21 – Oct 7, 2015
- Investigators
- Nebil A. Oumer· Qin Xu
- Observations
- 11
- Pages
- 6
- FEI number
- 3004562873
In short: On October 7, 2015, FDA issued a Form 483 with 11 observations to Cape Apothecary Inc. in Annapolis, Maryland (FEI 3004562873) after an inspection that ran Sep 21 – Oct 7, 2015. The investigators were Nebil A. Oumer and Qin Xu. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
- 04
Drug product containers were opt clean and sterilized and processed to remove pyrogenic properties to assure…
This inspection in context
Nebil A. Oumer
5 documents · 2012–2015
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Virginia.
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 11 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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.?
Nebil A. Oumer and Qin Xu are named on this Form 483, for the inspection of Sep 21 – Oct 7, 2015. Each investigator has a profile showing what they cite most.
When was Cape Apothecary Inc. inspected by FDA?
The inspection ran Sep 21 – Oct 7, 2015, and the Form 483 is dated October 7, 2015.
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.