New England Compounding Center
Form 483 issued February 10, 2003 · Framingham, Massachusetts
- Inspection
- Feb 10, 2003
- Investigators
- David J. Pels· Karen M. Risi
- Observations
- 3
- Pages
- 2
- FEI number
- 3003623877
In short: On February 10, 2003, FDA issued a Form 483 with 3 observations to New England Compounding Center in Framingham, Massachusetts (FEI 3003623877) after an inspection that ran Feb 10, 2003. The investigators were David J. Pels and Karen M. Risi. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (2×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
For the preparation of sterile drug products distributed by your firm (such as those intended for…
- 02
There are no written procedures pertaining to the handling of complaints, nor does your firm…
- 03
There was no documentation available for the handling and disposition ofreports ofpatient problems, complaints, adverse dmg…
This inspection in context
David J. Pels
1 document · 2003
Cites 211.198 (complaint files) more than any other section. Most of their documents are for sites in Massachusetts.
The firmNew England Compounding Center history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at New England Compounding Center?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected New England Compounding Center?
David J. Pels and Karen M. Risi are named on this Form 483, for the inspection of Feb 10, 2003. Each investigator has a profile showing what they cite most.
When was New England Compounding Center inspected by FDA?
The inspection ran Feb 10, 2003, and the Form 483 is dated February 10, 2003.
How do I get the full Form 483 for New England Compounding Center?
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.