Bell-More Labs, Inc
Form 483 issued March 13, 2015 · Hampstead, Maryland
- Inspection
- Mar 3 – Mar 13, 2015
- Investigators
- Rachel C. Harrington· Tajah L. Blackburn· Vipulchandr N. Dholakia
- Observations
- 7
- Pages
- 6
- FEI number
- 1150023
In short: On March 13, 2015, FDA issued a Form 483 with 7 observations to Bell-More Labs, Inc in Hampstead, Maryland (FEI 1150023) after an inspection that ran Mar 3 – Mar 13, 2015. The investigators were Rachel C. Harrington, Tajah L. Blackburn and Vipulchandr N. Dholakia. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 04
Equipment and utensils are not at appropriate intervals to prevent that would alter the safety, identity…
This inspection in context
Rachel C. Harrington
7 documents · 2012–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Maryland.
The firmBell-More Labs, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bell-More Labs, Inc?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Bell-More Labs, Inc?
Rachel C. Harrington, Tajah L. Blackburn and Vipulchandr N. Dholakia are named on this Form 483, for the inspection of Mar 3 – Mar 13, 2015. Each investigator has a profile showing what they cite most.
When was Bell-More Labs, Inc inspected by FDA?
The inspection ran Mar 3 – Mar 13, 2015, and the Form 483 is dated March 13, 2015.
How do I get the full Form 483 for Bell-More Labs, 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.