Ohm Laboratories, Inc.
Form 483 issued August 12, 2009 · Gloversville, New York
- Inspection
- Jul 13 – Aug 12, 2009
- Investigator
- Felix Maldonado
- Observations
- 24
- Pages
- 23
- FEI number
- 3001236657
In short: On August 12, 2009, FDA issued a Form 483 with 24 observations to Ohm Laboratories, Inc. in Gloversville, New York (FEI 3001236657) after an inspection that ran Jul 13 – Aug 12, 2009. The investigator was Felix Maldonado. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and quality system account for 14 of 23 observations.
Most cited: 21 CFR 211.166 (4×) · 211.194 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An annual report did not include information about the quantity of the drug product distributed under…
- 02
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 03
An adequate number of batches of each drug product are not tested nor are records of…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Felix Maldonado
6 documents · 2009–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmOhm Laboratories, 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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ohm Laboratories, Inc.?
FDA listed 24 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Ohm Laboratories, Inc.?
Felix Maldonado is named on this Form 483, for the inspection of Jul 13 – Aug 12, 2009. Each investigator has a profile showing what they cite most.
When was Ohm Laboratories, Inc. inspected by FDA?
The inspection ran Jul 13 – Aug 12, 2009, and the Form 483 is dated August 12, 2009.
How do I get the full Form 483 for Ohm 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.