Aptuit (Oxford) Ltd.
Form 483 issued July 22, 2016 · Milton, United Kingdom
- Inspection
- Jul 22, 2016
- Investigators
- Deyaa Shaheen· Jessica L. Pressley
- Observations
- 7
- Pages
- 6
- FEI number
- 3003444315
In short: On July 22, 2016, FDA issued a Form 483 with 7 observations to Aptuit (Oxford) Ltd. in Milton, Oxfordshire (FEI 3003444315) after an inspection that ran Jul 22, 2016. The investigators were Deyaa Shaheen and Jessica L. Pressley. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Laboratory controls and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's cleaning and maintenance of the CON water system located in Building Ap and…
- 02
Your firm's Environmental Monitoring Program for the classified areas (ISO 8) in Building q phere the…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Appropriate controls are not exercised over computers or related systems to assure changes in control records…
This inspection in context
Deyaa Shaheen
5 documents · 2016–2017
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Germany.
The firmAptuit (Oxford) Ltd. history
All 2 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 Aptuit (Oxford) Ltd.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Aptuit (Oxford) Ltd.?
Deyaa Shaheen and Jessica L. Pressley are named on this Form 483, for the inspection of Jul 22, 2016. Each investigator has a profile showing what they cite most.
When was Aptuit (Oxford) Ltd. inspected by FDA?
The inspection ran Jul 22, 2016, and the Form 483 is dated July 22, 2016.
How do I get the full Form 483 for Aptuit (Oxford) Ltd.?
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.