OBI Laboratories, Inc
Amended 483 issued May 14, 2019 · Fort Worth, Texas
- Inspection
- May 6 – May 14, 2019
- Investigators
- Michelle A. Krayer· Patty P. Kaewussdangkul
- Observations
- 1
- Pages
- 5
In short: On May 14, 2019, FDA issued a Amended 483 with 1 observation to OBI Laboratories, Inc in Fort Worth, Texas after an inspection that ran May 6 – May 14, 2019. The investigators were Michelle A. Krayer and Patty P. Kaewussdangkul. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this amended 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
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Michelle A. Krayer
11 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Texas.
The firmOBI Laboratories, Inc history
The site's inspection history, in date order.
Similar documentsOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at OBI Laboratories, Inc?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected OBI Laboratories, Inc?
Michelle A. Krayer and Patty P. Kaewussdangkul are named on this Amended 483, for the inspection of May 6 – May 14, 2019. Each investigator has a profile showing what they cite most.
When was OBI Laboratories, Inc inspected by FDA?
The inspection ran May 6 – May 14, 2019, and the Amended 483 is dated May 14, 2019.
How do I get the full Amended 483 for OBI Laboratories, 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.