Abbott's Compounding Pharmacy Inc.
Form 483 issued January 8, 2016 · Berkeley, California
- Inspection
- Dec 29, 2015 – Jan 8, 2016
- Investigators
- Ashar P. Parikh· Dustin P. Tran· Eileen A. Liu
- Observations
- 11
- Pages
- 9
- FEI number
- 3005529620
In short: On January 8, 2016, FDA issued a Form 483 with 11 observations to Abbott's Compounding Pharmacy Inc. in Berkeley, California (FEI 3005529620) after an inspection that ran Dec 29, 2015 – Jan 8, 2016. The investigators were Ashar P. Parikh, Dustin P. Tran and Eileen A. Liu. 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 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacturing and processing of a drug product are not maintained in a…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Protective apparel is not worn as necessary to protect…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
This inspection in context
Ashar P. Parikh
19 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmAbbott's Compounding Pharmacy Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Abbott's Compounding Pharmacy Inc.?
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 Abbott's Compounding Pharmacy Inc.?
Ashar P. Parikh, Dustin P. Tran and Eileen A. Liu are named on this Form 483, for the inspection of Dec 29, 2015 – Jan 8, 2016. Each investigator has a profile showing what they cite most.
When was Abbott's Compounding Pharmacy Inc. inspected by FDA?
The inspection ran Dec 29, 2015 – Jan 8, 2016, and the Form 483 is dated January 8, 2016.
How do I get the full Form 483 for Abbott's Compounding Pharmacy Inc.?
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