New England Compounding Center
Form 483 issued April 16, 2002 · Framingham, Massachusetts
- Inspection
- Apr 9 – Apr 16, 2002
- Investigators
- Kristina M. Joyce· Mark Lookabaugh
- Observations
- 4
- Pages
- 1
- FEI number
- 3003623877
In short: On April 16, 2002, FDA issued a Form 483 with 4 observations to New England Compounding Center in Framingham, Massachusetts (FEI 3003623877) after an inspection that ran Apr 9 – Apr 16, 2002. The investigators were Kristina M. Joyce and Mark Lookabaugh. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.113 (2×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Betamethasone Repository Injection (Betamethasone Acetate and Betamethasone Sodium Phosphate Suspension 6 mg/ml), a product which is…
- 02
The samples taken inunediately afte-com letion of the autoclave sterilization cycle are not representative ofproduct that…
- 03
The firm's validation of the autoclave cycle does not take into account the fact that the…
- 04
On at least one occasion, a lot number (Lot 02 01 2002@027) was generated in the…
This inspection in context
Kristina M. Joyce
5 documents · 2002–2003
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at New England Compounding Center?
FDA listed 4 observations on this Form 483, mostly about production and laboratory controls. 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 New England Compounding Center?
Kristina M. Joyce and Mark Lookabaugh are named on this Form 483, for the inspection of Apr 9 – Apr 16, 2002. Each investigator has a profile showing what they cite most.
When was New England Compounding Center inspected by FDA?
The inspection ran Apr 9 – Apr 16, 2002, and the Form 483 is dated April 16, 2002.
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.