ABC Pharmacy, Inc.
Form 483 issued December 20, 2019 · Encino, California
- Inspection
- Dec 12 – Dec 20, 2019
- Investigator
- Uttaniti Limchumroon
- Observations
- 2
- Pages
- 1
- FEI number
- 3015728736
In short: On December 20, 2019, FDA issued a Form 483 with 2 observations to ABC Pharmacy, Inc. in Encino, California (FEI 3015728736) after an inspection that ran Dec 12 – Dec 20, 2019. The investigator was Uttaniti Limchumroon. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.165 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm released drug product in which the strength differs from, or its purity or quality…
- 02
Hazardous drugs were produced without providing adequate cleaning of…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmABC Pharmacy, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ABC Pharmacy, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected ABC Pharmacy, Inc.?
Uttaniti Limchumroon is named on this Form 483, for the inspection of Dec 12 – Dec 20, 2019. Each investigator has a profile showing what they cite most.
When was ABC Pharmacy, Inc. inspected by FDA?
The inspection ran Dec 12 – Dec 20, 2019, and the Form 483 is dated December 20, 2019.
How do I get the full Form 483 for ABC 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.