Boston Analytical, Inc.
Form 483 issued November 9, 2012 · Salem, New Hampshire
- Inspection
- Nov 6 – Nov 9, 2012
- Investigators
- Abdur-Rafay Shareef· Charisse K. Green
- Observations
- 3
- Pages
- 3
- FEI number
- 1221426
In short: On November 9, 2012, FDA issued a Form 483 with 3 observations to Boston Analytical, Inc. in Salem, New Hampshire (FEI 1221426) after an inspection that ran Nov 6 – Nov 9, 2012. The investigators were Abdur-Rafay Shareef and Charisse K. Green. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Employees engaged in the processing of a drug product lack the training required to…
This inspection in context
Abdur-Rafay Shareef
1 document · 2012
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New Hampshire.
The firmBoston Analytical, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boston Analytical, Inc.?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Boston Analytical, Inc.?
Abdur-Rafay Shareef and Charisse K. Green are named on this Form 483, for the inspection of Nov 6 – Nov 9, 2012. Each investigator has a profile showing what they cite most.
When was Boston Analytical, Inc. inspected by FDA?
The inspection ran Nov 6 – Nov 9, 2012, and the Form 483 is dated November 9, 2012.
How do I get the full Form 483 for Boston Analytical, 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.