OL PHARMA TECH, LLC
Form 483 issued July 22, 2024 · madison heights, Michigan
- Inspection
- Jul 15 – Jul 22, 2024
- Investigators
- Joohi Castelvetere· Nicholas J. Presto
- Observations
- 9
- Pages
- 11
- FEI number
- 3017408112
In short: On July 22, 2024, FDA issued a Form 483 with 9 observations to OL PHARMA TECH, LLC in madison heights, Michigan (FEI 3017408112) after an inspection that ran Jul 15 – Jul 22, 2024. The investigators were Joohi Castelvetere and Nicholas J. Presto. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Joohi Castelvetere
9 documents · 2024–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Indiana.
The firmOL PHARMA TECH, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OL PHARMA TECH, LLC?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and production. 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 OL PHARMA TECH, LLC?
Joohi Castelvetere and Nicholas J. Presto are named on this Form 483, for the inspection of Jul 15 – Jul 22, 2024. Each investigator has a profile showing what they cite most.
When was OL PHARMA TECH, LLC inspected by FDA?
The inspection ran Jul 15 – Jul 22, 2024, and the Form 483 is dated July 22, 2024.
How do I get the full Form 483 for OL PHARMA TECH, LLC?
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