Bayview Pharmacy, Inc.
Form 483 issued August 18, 2016 · Saunderstown, Rhode Island
- Inspection
- Aug 9 – Aug 18, 2016
- Investigator
- Michael C. Chmiel
- Observations
- 4
- Pages
- 4
- FEI number
- 3011911677
In short: On August 18, 2016, FDA issued a Form 483 with 4 observations to Bayview Pharmacy, Inc. in Saunderstown, Rhode Island (FEI 3011911677) after an inspection that ran Aug 9 – Aug 18, 2016. The investigator was Michael C. Chmiel. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 4 of 4 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel were observed conducting aseptic manipulations or placing equipment/supplies in an area that blocked the movement…
- 02
The facility design was observed to allow the influx of poor quality air into…
- 03
Highly potent drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils…
- 04
Disinfecting agents Used in the ISO S area [aseptic processing…
This inspection in context
Michael C. Chmiel
1 document · 2016
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Rhode Island.
The firmBayview Pharmacy, Inc. history
The site's inspection history, in date order.
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 Bayview Pharmacy, Inc.?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. 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 Bayview Pharmacy, Inc.?
Michael C. Chmiel is named on this Form 483, for the inspection of Aug 9 – Aug 18, 2016. Each investigator has a profile showing what they cite most.
When was Bayview Pharmacy, Inc. inspected by FDA?
The inspection ran Aug 9 – Aug 18, 2016, and the Form 483 is dated August 18, 2016.
How do I get the full Form 483 for Bayview Pharmacy, 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.