Pacific Healthcare, Inc. dba B & B Pharmacy
Form 483 issued August 18, 2015 · Bellflo wer, California
- Inspection
- Aug 3 – Aug 18, 2015
- Investigators
- Ariel Cruz Figueroa· Binh T. Nguyen· Yasamin Ameri
- Observations
- 11
- Pages
- 12
- FEI number
- 3005530267
In short: On August 18, 2015, FDA issued a Form 483 with 11 observations to Pacific Healthcare, Inc. dba B & B Pharmacy in Bellflo wer, California (FEI 3005530267) after an inspection that ran Aug 3 – Aug 18, 2015. The investigators were Ariel Cruz Figueroa, Binh T. Nguyen and Yasamin Ameri. 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 9 of 11 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmPacific Healthcare, Inc. dba B & B Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pacific Healthcare, Inc. dba B & B Pharmacy?
FDA listed 11 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 Pacific Healthcare, Inc. dba B & B Pharmacy?
Ariel Cruz Figueroa, Binh T. Nguyen and Yasamin Ameri are named on this Form 483, for the inspection of Aug 3 – Aug 18, 2015. Each investigator has a profile showing what they cite most.
When was Pacific Healthcare, Inc. dba B & B Pharmacy inspected by FDA?
The inspection ran Aug 3 – Aug 18, 2015, and the Form 483 is dated August 18, 2015.
How do I get the full Form 483 for Pacific Healthcare, Inc. dba B & B Pharmacy?
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.